title: Continuous infusion of local anesthetic at iliac crest bone-graft sites for postoperative pain relief. A randomized, double-blind study. Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable. Valdecoxib for Postoperative Pain Management After Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Study Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis Measurement of health status. Ascertaining the minimal clinically important difference. Low-dose Intravenous Ketamine Potentiates Epidural Analgesia after Thoracotomy Clonidine Added to a Continuous Interscalene Ropivacaine Perineural Infusion to Improve Postoperative Analgesia: A Randomized, Double-Blind, Controlled Study Intravenous Lidocaine Relieves Spinal Cord Injury Pain: A Randomized Controlled Trial Premedication with Gabapentin: The Effect on Tourniquet Pain and Quality of Intravenous Regional Anesthesia Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Perioperative Nimodipine and Postoperative Analgesia Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale Aquatic Physical Therapy for Hip and Knee Osteoarthritis: Results of a Single-Blind Randomized Controlled Trial Treatment of Pain Attributed to Plantar Fasciitis with Botulinum Toxin A: A Short-Term, Randomized, Placebo-Controlled, Double-Blind Study Clinically important changes in acute pain outcome measures: a validation study. Intrauterine lignocaine as an anaesthetic during endometrial sampling: a randomised double-blind controlled trial. The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. Intravenous Regional Anesthesia Using Lidocaine and Magnesium Intramuscular Electrical Stimulation for Hemiplegic Shoulder Pain: A 12-Month Follow-Up of a Multiple-Center, Randomized Clinical Trial A Randomized Study of the Effects of Gabapentin on Postamputation Pain Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebo-controlled trial. Four Percent Intrauterine Lidocaine Infusion for Pain Management in First-Trimester Abortions A trial that compares Monsel's paste with ball electrode for hemostasis after loop electrosurgical excision procedure. The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomised controlled trial Botulinum Toxin Type A for Chronic Pain and Pelvic Floor Spasm in Women: A Randomized Controlled Trial Comparison of Morphine, Ketorolac, and Their Combination for Postoperative Pain: Results from a Large, Randomized, Double-blind Trial Improving the quality of reporting of randomized controlled trials. The CONSORT statement. A randomized controlled trial of deep water running: clinical effectiveness of aquatic exercise to treat fibromyalgia. Feeling good rather than feeling better matters more to patients. Combination of oral tramadol, acetaminophen and 1% lidocaine induced periprostatic nerve block for pain control during transrectal ultrasound guided biopsy of the prostate: a prospective, randomized, controlled trial. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Postoperative Analgesia After Major Spine Surgery: Patient-Controlled Epidural Analgesia Versus Patient-Controlled Intravenous Analgesia A single dose of gabapentin reduces acute pain and allodynia in patients with herpes zoster Effectiveness of Intrauterine Anesthesia for Pain Relief During Fractional Curettage Characterizing individual differences in heat-pain sensitivity Safety and efficacy of hydromorphone as an analgesic alternative to morphine in acute pain: a randomized clinical trial.
abstract: BACKGROUND Autologous bone graft is the so-called gold st and ard for reconstruction of bone defects and nonunions . The most frequent complication is donor site pain . The iliac crest is a common source for autologous bone graft . The purpose of this study was to determine whether a continuous infusion of 0.5 % bupivacaine into the iliac crest harvest site provides pain relief that is superior to the relief provided by systemic narcotic pain medication alone in patients undergoing reconstructive orthopaedic trauma procedures . METHODS A prospect i ve , double-blind r and omized study of patients over eighteen years of age who were undergoing harvesting of iliac crest bone graft was conducted . The patients were r and omized to the treatment arm ( bupivacaine infusion pump ) or the placebo arm . Postoperatively , all study patients received morphine sulfate with use of a patient-controlled analgesia pump . The patients recorded the pain at the donor and recipient sites with use of a scale ranging from 0 to 10 . The use of systemic narcotic medication was recorded . Independent- sample s t tests were used to assess differences in perceived pain relief between the treatment and control groups at zero , eight , sixteen , twenty-four , thirty-two , forty , and forty-eight hours after surgery . Pain was also assessed at two and six weeks postoperatively . RESULTS Sixty patients were enrolled . Across all data points , except pain at the recipient site at twenty-four hours , no significant differences in the perception of pain were found between the bupivacaine group and the placebo group . On the average , patients in the treatment group reported more pain than those in the control group . No significant difference was found between the two groups with regard to the amount of narcotic medication used . CONCLUSIONS No difference in perceived pain was found between the groups . The results of this small , unstratified study indicate that continuous infusion of bupivacaine at iliac crest bone-graft sites during the postoperative period is not an effective pain-control measure in hospitalized patients receiving systemic narcotic medication In r and omized controlled trials , no single definition of response is ideal for all purpose s. We propose a method to present in a simple fashion the likelihood of response over a full range of response levels , which will facilitate a better underst and ing of clinical trial data . We present the technique called the  cumulative proportion of responders analysis  ( CPRA ) and its application to four pain clinical trial data sets as examples . The CPRA can be used to present the proportion of responders over the entire range of possible cut-off points as a graph . This allows the reader to compare treatment groups at any responder level that is valid for their patient population . Whether as a primary or secondary approach to a clinical trial of pain therapy , the display of data in a CPRA format may be useful in the underst and ing of results and applicability to patient care Although nonsteroidal antiinflammatory drugs ( NSAIDs ) improve postoperative pain relief after cesarean delivery , they carry potential side effects ( e.g. , bleeding ) . Perioperative cyclooxygenase (COX)-2 inhibitors show similar analgesic efficacy to nonsteroidal antiinflammatory drugs in many surgical models but have not been studied after cesarean delivery . We design ed this r and omized double-blind study to determine the analgesic efficacy and opioid-sparing effects of valdecoxib after cesarean delivery . Healthy patients undergoing elective cesarean delivery under spinal anesthesia were r and omized to receive oral valdecoxib 20 mg or placebo every 12 h for 72 h postoperatively . As a result of cyclooxygenase-2 inhibitors safety concerns that became apparent during this study , the study was terminated early after evaluating 48 patients . We found no differences in total analgesic consumption between the valdecoxib and placebo groups ( 121 ± 70 versus 143 ± 77 morphine mg-equivalents , respectively ; P = 0.26 ) . Pain at rest and during activity were similar between the groups despite adequate post hoc power to have detected a clinical ly significant difference . There were also no differences in IV morphine requirements , time to first analgesic request , patient satisfaction , side effects , breast-feeding success , or functional activity . Postoperative pain was generally well controlled . Adding valdecoxib after cesarean delivery under spinal anesthesia with intrathecal morphine is not supported at this time Background : Central pain in multiple sclerosis ( MS ) is common and often refractory to treatment . Methods : We conducted a single-center , 5-week ( 1-week run-in , 4-week treatment ) , r and omized , double-blind , placebo-controlled , parallel-group trial in 66 patients with MS and central pain states ( 59 dysesthetic , seven painful spasms ) of a whole-plant cannabis-based medicine ( CBM ) , containing delta-9-tetrahydrocannabinol : cannabidiol ( THC : CBD ) delivered via an oromucosal spray , as adjunctive analgesic treatment . Each spray delivered 2.7 mg of THC and 2.5 of CBD , and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours . Results : Sixty-four patients ( 97 % ) completed the trial , 34 received CBM . In week 4 , the mean number of daily sprays taken of CBM ( n = 32 ) was 9.6 ( range 2 to 25 , SD = 6.0 ) and of placebo ( n = 31 ) was 19.1 ( range 1 to 47 , SD = 12.9 ) . Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale . CBM was superior to placebo in reducing the mean intensity of pain ( CBM mean change −2.7 , 95 % CI : −3.4 to −2.0 , placebo –1.4 95 % CI : −2.0 to −0.8 , comparison between groups , p = 0.005 ) and sleep disturbance ( CBM mean change –2.5 , 95 % CI : −3.4 to −1.7 , placebo –0.8 , 95 % CI : −1.5 to −0.1 , comparison between groups , p = 0.003 ) . CBM was generally well tolerated , although more patients on CBM than placebo  reported dizziness , dry mouth , and somnolence . Cognitive side effects were limited to long-term memory storage . Conclusions : Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background : Ketamine potentiates intravenous or epidural morphine analgesia . The authors hypothesized that very-low-dose ketamine infusion reduces acute and long-term postthoracotomy pain . Methods : Forty-nine patients scheduled to undergo open thoracotomy were r and omly assigned to receive one of two anesthesia regimens : continuous epidural infusion of ropivacaine and morphine , along with intravenous infusion of ketamine ( 0.05 mg · kg−1 · h−1 [ approximately 3 mg/h ] , ketamine group , n = 24 ) or placebo ( saline , control group , n = 25 ) . Epidural analgesia was continued for 2 days after surgery , and infusion of ketamine or placebo was continued for 3 days . Pain was assessed at 6 , 12 , 24 , and 48 h after surgery . Patients were asked about their pain , abnormal sensation on the wound , and inconvenience in daily life at 7 days and 1 , 3 , and 6 months after surgery . Results : The visual analog scale scores for pain at rest and on coughing 24 and 48 h after thoracotomy were lower in the ketamine group than in the control group ( pain at rest , 9 ± 11 vs. 25 ± 20 and 9 ± 11 vs. 18 ± 13 ; pain on coughing , 26 ± 16 vs. 50 ± 17 and 30 ± 18 vs. 43 ± 18 , mean ± SD ; P = 0.002 and P = 0.01 , P < 0.0001 and P = 0.02 , respectively ) . The numerical rating scale scores for baseline pain 1 and 3 months after thoracotomy were significantly lower in the ketamine group ( 0.5 [ 0–4 ] vs. 2 [ 0–5 ] and 0 [ 0–5 ] vs. 1.5 [ 0–6 ] , median [ range ] , respectively ; P = 0.02 ) . Three months after surgery , a higher number of control patients were taking pain medication ( 2 vs. 9 ; P = 0.03 ) . Conclusions : Very-low-dose ketamine ( 0.05 mg · kg−1 · h−1 ) potentiated morphine-ropivacaine analgesia and reduced postthoracotomy pain Although clonidine has been shown to increase the duration of local anesthetic action and prolong postoperative analgesia when included in single-injection nerve blocks , the only controlled investigation of the efficacy of this practice to improve analgesia for continuous perineural local anesthetic infusion failed to discern any clinical ly relevant benefits . For this study , we used a larger dose of clonidine in an attempt to improve analgesia . Patients ( n = 20 ) undergoing moderately painful orthopedic surgery of the shoulder received an  interscalene brachial plexus block ( 40 mL of mepivacaine 1.5 % , epinephrine 2.5 & mgr;g/mL , and clonidine 50 & mgr;g ) and a perineural catheter before surgery . After surgery , ropivacaine 0.2 % or ropivacaine 0.2 % plus clonidine 2 & mgr;g/mL was delivered via the catheter for 3 days ( basal rate , 5 mL/h ; patient-controlled bolus , 5 mL ; lockout , 1 h ) . Investigators and patients were blind to r and om group assignment . The primary outcome variable was design ated as the most intense pain during the day after surgery . Secondary end-points included additional pain scores , patient-controlled bolus doses , oral analgesic use , sleep quality , and catheter- or infusion-related complications . There were no statistically significant differences between groups for any of the variables investigated . We conclude that adding clonidine 2 & mgr;g/mL to a ropivacaine interscalene perineural infusion does not decrease breakthrough pain intensity the day after surgery . For the additional end-points , our negative findings are only suggestive of a lack of effect and require further study for verification Background : Neuropathic pain in spinal cord injury is a common challenging therapeutic condition . The current study examines the analgesic effect of the sodium channel blocker lidocaine on neuropathic pain in patients with spinal cord injury and the predictive role of concomitant evoked pain on pain relief with lidocaine . Methods : Twenty-four spinal cord injury patients with neuropathic pain at or below the level of injury were r and omized and completed a double-blind crossover trial of 5 mg/kg lidocaine and placebo infused over 30 min . Twelve patients reported evoked pain , and 12 patients had no evoked pain . Spontaneous and evoked pains were assessed using a visual analog scale and quantitative sensory testing . Results : Lidocaine significantly reduced spontaneous pain in all patients ( P < 0.01 ) and in each of the two groups with ( P < 0.01 ) and without ( P = 0.048 ) evoked pain , with no difference in number of responders ( pain reduction ≥ 33 % ) between the patients with ( n = 6 ) and without ( n = 5 ) evoked pain . Lidocaine significantly relieved both at-level and below-level neuropathic pain and decreased brush-evoked dysesthesia but not cold allodynia , pinprick hyperalgesia , or pain evoked by repetitive pinprick . Conclusions : Lidocaine reduced neuropathic pain at and below the level of injury irrespective of the presence or absence of evoked pain . Results are consistent with a central -acting effect of sodium channel blockers acting on neuronal hyperexcitability . Agents ( such as anticonvulsants or antiarrhythmics ) with sodium channel – blocking properties may be a treatment option for spinal cord injury pain BACKGROUND : Gabapentin , an oral non-opioid analgesic , has been used to decrease pain after a variety of surgical procedures . We hypothesized that premedication with gabapentin would minimize tourniquet-related pain in patients receiving IV regional anesthesia ( IVRA ) . METHODS : Patients undergoing elective h and surgery with IVRA were r and omly assigned to one of two study groups using a double-blind study design . The control group ( n = 20 ) received placebo capsules 1 h before the surgery , and the gabapentin  group ( n = 20 ) received gabapentin 1.2 g p.o . before the operation . IVRA was achieved in all patients with lidocaine , 3 mg/kg , diluted with saline to a total volume of 40 mL. Fentanyl , 0.5 & mgr;g/kg IV , was administered as a rescue analgesic during surgery . Sensory and motor block onset and recovery times , tourniquet pain , and quality of anesthesia were assessed at specific time intervals during the perioperative period . Visual analog scale pain scores ( 0–10 ) were recorded during the 24 h follow-up period , and patients received diclofenac , 75 mg IM , if their pain score was > 4 . RESULTS : The onset of the sensory and motor block did not differ between the two study groups . However , tourniquet pain scores at 30 , 40 , 50 , and 60 min after cuff inflation were lower in the gabapentin group ( P < 0.05 ) . The time to intraoperative analgesic rescue was prolonged in the gabapentin group ( 35 ± 10 min vs 21 ± 13 min , P < 0.05 ) , and less supplemental fentanyl was required ( 35 ± 47 & mgr;g vs 83 ± 73 & mgr;g , P < 0.05 ) . The quality of anesthesia , as independently assessed by the anesthesiologist and the surgeon , was significantly better in the gabapentin ( versus control ) group . In the gabapentin group , the time to requesting a rescue analgesic after surgery was prolonged ( 135 ± 25 min vs 85 ± 19 min , P < 0.05 ) , and postoperative pain scores at 60 min ( 3.8 ± 0.9 vs 2.2 ± 0.5 ) and 120 min ( 3.2 ± 1.4 vs 1.8 ± 0.8 ) , as well as diclofenac consumption ( 30 ± 38 mg vs 60 ± 63 mg ) , were reduced after surgery . CONCLUSIONS : Premedication with oral gabapentin ( 1.2 g ) decreased tourniquet-related pain and improved the quality of anesthesia during h and surgery under IVRA . Gabapentin also reduced pain scores in the early postoperative period BACKGROUND Lateral epicondylitis is a common condition for which botulinum toxin has been reported to have a therapeutic role in uncontrolled studies . OBJECTIVE To determine if an injection of botulinum toxin is more effective than placebo for reducing pain in adults with lateral epicondylitis . DESIGN R and omized , double-blind , placebo-controlled trial conducted from September 2002 to December 2004 . SETTING Outpatient clinics at a university hospital and a district hospital in Hong Kong . PARTICIPANTS 60 patients with lateral epicondylitis . MEASUREMENTS The primary outcome was change in subjective pain as measured by a 100-mm visual analogue scale ( VAS ) ranging from 0 ( no pain ) to 10 ( worst pain ever ) at 4 weeks and 12 weeks . All patients completed post-treatment follow-up . INTERVENTIONS A single injection of 60 units of botulinum toxin type A or normal saline placebo . RESULTS Mean VAS scores for the botulinum group at baseline and at 4 weeks were 65.5 mm and 25.3 mm , respectively ; respective scores for the placebo group were 66.2 mm and 50.5 mm ( between-group difference of changes , 24.4 mm [ 95 % CI , 13.0 to 35.8 mm ] ; P < 0.001 ) . At week 12 , mean VAS scores were 23.5 mm for the botulinum group and 43.5 mm for the placebo group ( between-group difference of changes , 19.3 mm [ CI , 5.6 to 32.9 mm ] ; P = 0.006 ) . Grip strength was not statistically significantly different between groups at any time . Mild paresis of the fingers occurred in 4 patients in the botulinum group at 4 weeks . One patient 's symptoms persisted until week 12 , whereas none of the patients receiving placebo had the same complaint . At 4 weeks , 10 patients in the botulinum group and 6 patients in the placebo group experienced weak finger extension on the same side as the injection site . LIMITATIONS The trial was small , and most participants were women . The blinding protocol may have been ineffective because the 4 participants who experienced paresis of the fingers could have correctly assumed that they received an active treatment . CONCLUSIONS Botulinum toxin injection may improve pain over a 3-month period in some patients with lateral epicondylitis , but injections may be associated with digit paresis and weakness of finger extension There is experimental evidence that nimodipine , an L-type dihydropiridine calcium channel blocker with relatively high blood-brain barrier penetration , enhances the antinociceptive properties of morphine . We tested the hypothesis that oral nimodipine taken preoperatively and 6 hourly for 48 h postoperatively would reduce visual analog scale pain scores and morphine consumption in morphine-naive patients with acute postoperative pain . Forty patients undergoing total knee replacement surgery ( age 70 ± 7 yr , 28 male ) were r and omized by computer-generated numbers to receive capsules containing either nimodipine 30 mg or placebo in a double-blind study design . All patients received 3 capsules ( nimodipine 90 mg or placebo ) 1–2 h before induction of anesthesia followed by oral nimodipine 30 mg or placebo 6 hourly for 48 hours postoperatively . Spinal anesthesia was induced with hyperbaric bupivacaine 0.5 % ( 2.4–3.0 mL ) and fluids and ephedrine were given at the discretion of the anesthesiologist . Morphine patient-controlled analgesia ( PCA , bolus 1 mg , lockout 5 min ) was given for postoperative analgesia . Primary outcome measures were visual analog pain scores at rest and on moving ( sitting forward ) and PCA morphine consumption . Morphine consumption was significantly larger in nimodipine patients at 12 h ( 39 ± 18 versus 29 ± 15 ; P = 0.04 ) , 24 h ( 62 ± 23 versus 45 ± 24 ; P = 0.02 ) , and 48 h ( 88 ± 34 versus 61 ± 27 ; P = 0.01 ) . There were no significant differences in pain scores at rest or moving or in time to first use of morphine analgesia . This study has demonstrated increased morphine consumption after 12 h in postoperative patients receiving nimodipine , suggesting that , in patients undergoing knee replacement surgery , it has no adjunctive analgesic effect and may actually inhibit the analgesic effect of morphine & NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response Babcock MS , Foster L , Pasquina P , Jabbari B : Treatment of pain attributed to plantar fasciitis with botulinum toxin A : A short-term , r and omized , placebo-controlled , double-blind study . Am J Phys Med Rebabil 2005;84:649–654 . Objective : To investigate the effect of botulinum toxin A on associated pain and functional impairment of refractory plantar fasciitis . Design : This is a r and omized , double-blind , placebo-controlled study of 27 patients ( 43 feet ) with plantar fasciitis . Block r and omization was performed using computer software . In patients with bilateral symptoms of comparable severity , botulinum toxin A was injected in one foot and saline in the other foot . The treatment group received a total of 70 units of botulinum toxin A divided into two sites per foot . One of the two sites was the tender area in the medial aspect of the heel close to the calcaneal tuberosity ( 40 units ) , and the other was in the arch of the foot between an inch anterior to the heel and middle of the foot ( 30 units ) . The placebo group received the same volume of normal saline . Main outcome measures included : Pain Visual Analog Scale , Maryl and Foot Score , Pain Relief Visual Analog Scale , and pressure algometry response . Patients were assessed before injection , at 3 wks , and at 8 wks . Results : The study revealed statistically significant changes in the treatment group . Compared with placebo injections , the botulinum toxin A group improved in all measures : Pain Visual Analog Scale ( P < 0.005 ) , Maryl and Foot Score ( P = 0.001 ) , Pain Relief Visual Analog Scale ( P < 0.0005 ) , and pressure algometry response ( P = 0.003 ) . No side effects were noted . Conclusions : Botulinum toxin A injection for plantar fasciitis yields significant improvements in pain relief and overall foot function at both 3 and 8 wks after treatment The purpose of this study was to vali date the changes in acute pain measurement scales that are most strongly associated with a patient-determined indicator of clinical importance . Measures of pain intensity and pain relief are commonly used outcomes in therapeutic clinical trials . Recent studies of the properties of acute pain measures have provided data defining the cut-off points that are best associated with clinical ly important differences . Validation of these findings in another clinical trial data set is important . Data were obtained from the titration phase of a recently conducted r and omized controlled clinical trial of oral transmucosal fentanyl citrate ( OTFC ) , which compared OTFC to immediate release morphine sulfate ( MSIR ) for the treatment of cancer-related acute breakthrough pain .  Changes in pain intensity and pain relief were recorded every 15 minutes for 60 minutes and global medication performance recorded at the end of each study pain episode . At any titration step , if the patient felt that the first dose of the study medication did not provide adequate relief within 30 minutes , an additional rescue medication could be taken . To find the level of each pain scale best associated with this measure of the adequacy of pain relief , the calculated sensitivity , specificity , and accuracy for different cut-off points of the measured pain scales were compared to whether or not the patient needed rescue medication . The overall ability of the pain measures to discriminate episodes for which a rescue was not needed was calculated using area under the receiver operating characteristics ( ROC ) curves . Data were analyzed from 134 OTFC-naive patients who collected data on 1307 episodes of breakthrough pain . Using the criteria of a balanced sensitivity and specificity , the best cut-off points were determined to be : 33 % for the percent pain intensity difference ; > or = 2 for the raw pain intensity difference on a 0 - 10 numeric rating scale ; > or = 2 ( i.e. , moderate or better ) for pain relief ; > or = 33 % for the percent maximum total pain relief ; and > or = 2 ( good or better ) for global medication performance . ROC area under the curve ranged from 0.839 to 0.862 for each of the pain measures listed above , calculated at 60 minutes . These data indicate that the pain scale cut-off points that are best associated with a patient-derived measure of a clinical ly important difference closely approximate those found in an earlier study . ROC analysis provided evidence that the overall pain measures were strongly associated with not requiring an " additional dose of rescue medication . " Thus , the cut-off points determined for these pain scales provide a good surrogate measure of a patient-determined clinical ly important response . This provides support for the usefulness of these values in future clinical trials of pain therapy OBJECTIVE To evaluate the effectiveness of intrauterine lignocaine as an anaesthetic during endometrial sampling . DESIGN Prospect i ve , r and omised , double-blind , placebo-controlled trial . SETTING Outpatient gynaecological minor operation unit in a public hospital . POPULATION Two hundred premenopausal women scheduled for endometrial sampling because of abnormal uterine bleeding . METHODS Transcervical intrauterine instillation of 5 mL of 2 % lignocaine or 5 mL of normal saline before performing endometrial sampling with vacuum aspirator . MAIN OUTCOME MEASURES Evaluation of pain associated with the procedure using a visual analogue scale . RESULTS The use of intrauterine lignocaine reduced pain during suction curettage in endometrial sampling . CONCLUSIONS Transcervical instillation of lignocaine reduced pain during endometrial sampling PURPOSE The aim of this study was to compare the analgesic efficacy of single-dose preoperative intravenous versus oral tramadol for preventing pain after third molar surgery . PATIENTS AND METHODS Seventy-two patients undergoing elective third molar surgery were r and omized to receive either intravenous ( n = 36 ) or oral ( n = 36 ) tramadol 50 mg . The intravenous group received an oral placebo capsule followed by intravenous tramadol 50 mg preoperatively . The oral tramadol group received a 50-mg oral tramadol capsule followed by intravenous placebo saline preoperatively . In both groups , a st and ard intravenous sedation technique was administered and the impacted third molars were removed under local anesthesia . The difference in postoperative pain was assessed by 4 primary end points : hourly pain intensity as measured by a 100-mm visual analog scale for 8 hours , time to rescue analgesic , postoperative acetaminophen consumption , and a 5-point global assessment scale ( 0 = poor , 1 = fair , 2 = good , 3 = very good , and 4 = excellent ) . RESULTS Throughout the 8-hour investigation period , patients reported significantly lower pain intensity scores in the intravenous versus oral group ( 15.9 + /- 9.6 mm versus 36.9 + /- 17.2 mm , P = .03 ) . Patients also reported significantly longer time to rescue analgesic ( 7.0 hours versus 3.5 hours , P = .00001 ) , lesser postoperative acetaminophen consumption ( 1,823 + /- 1,266 mg versus 3,558 + /- 1,418 mg , P = .000006 ) , and better global assessment ( 2.6 + /- 0.9 versus 1.1 + /- 0.8 , P = .01 ) for the intravenous versus oral group . CONCLUSIONS We conclude that preoperative intravenous tramadol is superior to oral tramadol for preventing postoperative pain following third molar surgery . However , it should be noted that there is a difference in the bioavailability between the 2 formulations of up to 30 % , which may explain the findings We conducted this study to evaluate the effects of magnesium , when added to lidocaine for IV regional anesthesia ( IVRA ) , on tourniquet pain . Thirty patients undergoing elective h and surgery during IVRA were r and omly assigned to two groups . IVRA was achieved with 10 mL of saline plus 3 mg/kg lidocaine 0.5 % diluted with saline to a total of 40 mL in group C or with 10 mL of 15 % magnesium sulfate ( 12.4 mmol ) plus 3 mg/kg lidocaine 0.5 % diluted with saline to a total of 40 mL in group M. Injection pain , sensory and motor block onset and recovery time , tourniquet pain , and anesthesia quality were noted . Patients were instructed to receive 75 mg of IM diclofenac when the visual analog scale ( VAS ) score was > 4 , and analgesic requirements were recorded . Sensory and motor block onset times were shorter and recovery times were prolonged in group M ( P < 0.05 ) . VAS scores of tourniquet pain were lower in group M at 15 , 20 , 30 , 40 , and 50 min ( P < 0.001 ) . Anesthesia quality , as determined by the anesthesiologist and surgeon , was better in group M ( P < 0.05 ) . Time to the first postoperative analgesic request in group C was 95 ± 29 min and in group M was 155 ± 38 min ( P < 0.05 ) . Postoperative VAS scores were higher for the first postoperative 6 h in group C ( P <  0.05 ) . Diclofenac consumption was significantly less in group M ( 50 ± 35 mg ) when compared with group C ( 130 + 55 mg ) ( P < 0.05 ) . We conclude that magnesium as an adjunct to lidocaine  improves the quality of anesthesia and analgesia in IVRA Chae J , Yu DT , Walker ME , Kirsteins A , Elovic EP , Flanagan SR , Harvey RL , Zorowitz RD , Frost FS , Grill JH , Fang ZP : Intramuscular electrical stimulation for hemiplegic shoulder pain : A 12-month follow-up of a multiple-center , r and omized clinical trial . Am J Phys Med Rehabil 2005;84:832–842 . Objective : Assess the effectiveness of intramuscular electrical stimulation in reducing hemiplegic shoulder pain at 12 mos posttreatment . Design : A total of 61 chronic stroke survivors with shoulder pain and subluxation participated in this multiple-center , single-blinded , r and omized clinical trial . Treatment subjects received intramuscular electrical stimulation to the supraspinatus , posterior deltoid , middle deltoid , and upper trapezius for 6 hrs/day for 6 wks . Control subjects were treated with a cuff-type sling for 6 wks . Brief Pain Inventory question 12 , an 11-point numeric rating scale was administered in a blinded manner at baseline , end of treatment , and at 3 , 6 , and 12 mos posttreatment . Treatment success was defined as a minimum 2-point reduction in Brief Pain Inventory question 12 at all posttreatment assessment s. Secondary measures included pain-related quality of life ( Brief Pain Inventory question 23 ) , subluxation , motor impairment , range of motion , spasticity , and activity limitation . Results : The electrical stimulation group exhibited a significantly higher success rate than controls ( 63 % vs. 21 % , P = 0.001 ) . Repeated-measure analysis of variance revealed significant treatment effects on posttreatment Brief Pain Inventory question 12 ( F = 21.2 , P < 0.001 ) and Brief Pain Inventory question 23 ( F = 8.3 , P < 0.001 ) . Treatment effects on other secondary measures were not significant . Conclusions : Intramuscular electrical stimulation reduces hemiplegic shoulder pain , and the effect is maintained for ≥12 mos posttreatment Background : Pain after amputation is common but difficult to treat . Therefore , the authors examined whether postoperative treatment with gabapentin could reduce postamputation stump and phantom pain . Methods : Forty-six patients scheduled to undergo lower limb amputation were r and omly assigned to receive oral gabapentin or placebo . Treatment was started on the first postoperative day and continued for 30 days . The daily dose of gabapentin or placebo was gradually increased to 2,400 mg/day . The intensity of stump and phantom pain was recorded every day on a numeric rating scale ( 0–10 ) during the 30-day treatment period . Five interviews were performed after 7 , 14 , and 30 days and after 3 and 6 months . Results : Results from 41 patients were included in the data analysis . The risk of phantom pain  ( gabapentin vs. placebo ) was 55.0 % versus 52.6 % ( risk difference , 2.4 % ; 95 % confidence interval , −28.9 to 33.7 % ; P = 0.88 ; 30 days ) and 58.8 % versus 50.0 % ( risk difference , 8.8 % ; 95 % confidence interval , −23.3 to 40.9 % ; P = 0.59 ; 6 months ) . The median intensity of phantom pain  ( gabapentin vs. placebo ) was 1.5 ( range , 0–9.0 ) versus 1.2 ( range , 0–6.6 ) ( P = 0.60 ; 30 days ) and 1.0 ( range , 0–6.0 ) versus 0.5 ( range , 0–5.0 ) ( P = 0.77 ; 6 months ) . The median intensity of stump pain was 0.85 ( range , 0–8.2 ) versus 1.0 ( range , 0–5.4 ) ( P = 0.68 ; 30 days ) and 0 ( range , 0–8.0 ) versus 0 ( range , 0–5.0 ) ( P = 0.58 ; 6 months ) . Conclusion : Gabapentin administered in the first 30 postoperative days after amputation does not reduce the incidence or intensity of postamputation pain OBJECTIVE Although common treatments for osteoarthritis ( OA ) pain , such as nonsteroidal antiinflammatory drugs ( NSAIDs ) , simple analgesics , and weak opioids , provide relief in some cases , they fail to control pain or are poorly tolerated in many cases . Strong opioids have been used to successfully treat several types of noncancer pain but have rarely been tested in controlled studies . Therefore , we tested the effects of transdermal fentanyl ( TDF ) in patients with moderate-to-severe OA pain , in a placebo-controlled study . METHODS The cohort comprised patients with radiologically confirmed OA of the hip or knee ( meeting the American College of Rheumatology criteria ) requiring joint replacement and with moderate-to-severe pain that had been inadequately controlled by weak opioids . The patients were r and omized to receive TDF or placebo for 6 weeks after a 1-week pretreatment run-in phase . During study treatment , previously prescribed NSAIDs and simple analgesics were continued , but weak opioids were discontinued . All patients had access to paracetamol and metoclopramide . Pain was recorded on a visual analog scale ( VAS ) , and function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . RESULTS Data were available for 399 patients ( 202 receiving TDF , 197 receiving placebo ) , of whom 199 ( 50 % ) completed the study . TDF provided significantly better pain relief than placebo , as demonstrated by the primary outcome measure ( area under the curve for VAS scores -20 in the TDF group versus -14.6 in the placebo group ; P = 0.007 ) . TDF was also associated with significantly better overall WOMAC scores and pain scores . The most common adverse events were nausea , vomiting , and somnolence , and these occurred more often in the TDF group . CONCLUSION TDF can reduce pain and improve function in patients with knee or hip OA OBJECTIVE : To study the effects of a 4 % intrauterine lidocaine infusion on perceived patient pain in first-trimester abortions . METHODS : A r and omized , double-blind , placebo-controlled trial of 80 women receiving either a 5-mL 4 % lidocaine ( n = 40 ) or saline ( n = 40 ) intrauterine infusion and a st and ard paracervical block before first-trimester abortion . Women completed a series of 100-mm visual analog scales ( anchors : 0 = none , 100 mm = worst imaginable ) to measure their perceived pain ( anticipated pain , after speculum insertion , after intrauterine infusion , after cervical dilation , after suction aspiration , and 30 minutes postprocedure ) . Eight women volunteered for serum lidocaine levels after the lidocaine infusion . RESULTS : Groups were similar in respect to age , parity , prior abortion , ethnicity , gestational age , and level of dysmenorrhea .  Pain scores demonstrated a significant difference between groups during cervical dilation ( saline 55 mm ± 26 , lidocaine 35 mm ± 30 , P < .01 ) and during aspiration ( saline 71 mm ± 20 , lidocaine 43 mm ± 30 , P < .01 ) . The lidocaine group reported significantly more symptoms ( ie , oral numbness and tingling ) than the saline group ( saline 0/39 , lidocaine 16/38 , 42 % , P < .01 ) . The highest serum lidocaine level recorded was 4.0 & mgr;g/mL ( lidocaine group ) . There was no difference in overall satisfaction between the 2 groups . CONCLUSION : Compared with paracervical block alone , the addition of a 4 % intrauterine lidocaine infusion result ed in a significant reduction in patient perception of pain during first-trimester abortion . Although subjective symptoms of systemic lidocaine effect were common , no subjects demonstrated serum levels consistent with lidocaine toxicity . However , further studies to determine safety are needed . LEVEL OF EVIDENCE : OBJECTIVE The purpose of this study was to compare Monsel 's paste with fulguration with ball electrode for hemostasis after loop electrosurgical excision procedure . STUDY DESIGN One hundred healthy women were assigned r and omly by computer-generated r and om numbers to ball electrode or thickened Monsel 's paste for hemostasis after loop electrosurgical excision procedure . Patients rated pain during hemostasis using a visual analog scale . At 2 weeks , postprocedural vaginal discharge was rated on a Likert scale . Pathology was review ed for dysplasia grade and margin status . Recurrent dysplasia on repeat Papanicolaou tests was noted . RESULTS Six patients ( 2 Monsel 's and 4 fulguration ) required an alternate method of hemostasis . Patient demographics , postprocedural discharge , and recurrent dysplasia were comparable between the 2 groups . Visual analog scale scores and hemostasis time were significantly higher in the fulguration group . Estimated blood loss , although higher in the fulguration group , was not significant between groups . CONCLUSION Monsel 's paste and fulguration with ball electrode appear be equally effective as hemostatic agents after loop electrosurgical excision procedure BACKGROUND Postherpetic neuralgia is the most frequent complication of herpes zoster . Treatment of this neuropathic pain syndrome is difficult and often disappointing . We assessed the effectiveness of a single epidural injection of steroids and local anaesthetics for prevention of postherpetic neuralgia in older patients with herpes zoster . METHODS We r and omly assigned 598 patients older than 50 years , with acute herpes zoster ( rash < 7 days ) below dermatome C6 , to receive either st and ard therapy ( oral antivirals and analgesics ) or st and ard therapy with one additional epidural injection of 80 mg methylprednisolone acetate and 10 mg bupivacaine . The primary endpoint was the proportion of patients with zoster-associated pain 1 month after inclusion . Analyses were by intention-to-treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N32866390 . FINDINGS At 1 month , 137 ( 48 % ) patients in the epidural group reported pain compared with 164 ( 58 % ) in the control group ( relative risk [ RR ] 0.83 , 95 % CI 0.71 - 0.97 , p=0.02 ) . After 3 months these values were 58 ( 21 % ) and 63 ( 24 % ) respectively ( 0.89 , 0.65 - 1.21 , p=0.47 ) and , at 6 months , 39 ( 15 % ) and 44 ( 17 % ; 0.85 , 0.57 - 1.13 , p=0.43 ) . We detected no subgroups in which the relative risk for pain 1 month after inclusion substantially differed from the overall estimate . No patient had major adverse events related to epidural injection . INTERPRETATION A single epidural injection of steroids and local anaesthetics in the acute phase of herpes zoster has a modest effect in reducing zoster-associated pain for 1 month . This treatment is not effective for prevention of long-term postherpetic neuralgia OBJECTIVE : To estimate whether botulinum toxin type A is more effective than placebo at reducing pain and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm . METHODS : This study was a double-blinded , r and omized , placebo-controlled trial . All participants presented with chronic pelvic pain of more than 2 years duration and evidence of pelvic floor muscle spasm . Thirty women had 80 units of botulinum toxin type A injected into the pelvic floor muscles , and 30 women received saline .  Dysmenorrhea , dyspareunia , dyschezia , and nonmenstrual pelvic pain were assessed by visual analog scale ( VAS ) at baseline and then monthly for 6 months . Pelvic floor pressures were measured by vaginal manometry . RESULTS : There was significant change from baseline in the botulinum toxin type A group for dyspareunia ( VAS score 66 versus 12 ; χ2=25.78 , P<.001 ) and nonmenstrual pelvic pain ( VAS score 51 versus 22 ; χ2=16.98 , P=.009 ) . In the placebo group only dyspareunia was significantly reduced from baseline ( 64 versus 27 ; χ2=2.98 , P=.043 ) . There was a significant reduction in pelvic floor pressure ( centimeters of H2O ) in the botulinum toxin type A group from baseline ( 49 versus 32 ; χ2=39.53 , P<.001 ) , with the placebo group also having lower pelvic floor muscle pressures ( 44 versus 39 ; χ2=19.85 , P=.003 ) . CONCLUSION : Objective reduction of pelvic floor spasm reduces some types of pelvic pain . Botulinum toxin type A reduces pressure in the pelvic floor muscles more than placebo . Botulinum toxin type A may be a useful agent in women with pelvic floor muscle spasm and chronic pelvic pain who do not respond to conservative physical therapy . Clinical Trial Registration : Australian Clinical Trials Registry , http://www.actr.org.au/ , ACTRN012605000515695 LEVEL OF EVIDENCE : Background : Meta-analyses report similar numbers needed to treat for nonsteroidal antiinflammatory drugs ( NSAIDs ) and opioids . Differences in baseline pain intensity among the studies from which these numbers needed to treat were derived may have confounded the results . NSAIDs have an opioid-sparing effect , but the importance of this effect is unclear . Therefore , the authors sought to compare the proportions of subjects who obtain pain relief with ketorolac versus morphine after surgery and to determine whether the opioid-sparing effect of an NSAID reduces the magnitude of opioid side effects . Methods : The study was a double-blind , r and omized controlled trial . The authors r and omly assigned 1,003 adult patients to receive 30 mg  ketorolac  or 0.1 mg/kg morphine intravenously . They calculated the proportion of subjects who achieved at least 50 % reduction in pain intensity 30 min after analgesic administration . Further , so long as pain intensity 30 min after analgesic administration was 5 or more out of 10 , patients received 2.5 mg morphine every 10 min until pain intensity was 4 or less out of 10 . The authors assessed the presence of opioid-related side effects . Results : Five hundred patients received morphine and 503 received ketorolac .  Fifty percent of patients in the morphine group achieved pain relief , compared with 31 % in the ketorolac group ( difference , 19 % ; 95 % confidence interval , 13–25 % ) . The ketorolac – morphine group required less morphine ( difference , 6.5 mg ; 95 % confidence interval , −5.8 to −7.2 ) and had a lower incidence of side effects ( difference , 11 % ; 95 % confidence interval , 5–16 % ) than the morphine group . Conclusions : Opioids are more efficacious analgesics than NSAIDs , although historic data for these two drugs yield similar numbers needed to treat . Adding NSAIDs to the opioid treatment reduces morphine requirements and opioid-related side effects in the early postoperative period THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard OBJECTIVE To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia ( FM ) . METHODS Sixty sedentary women with FM , ages 18 - 60 years , were r and omly assigned to either deep water running ( DWR ) or l and -based exercises ( LBE ) . Patients were trained for 15 weeks at their anaerobic threshold .  Visual analog scale of pain , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory , Short Form 36 Health Survey ( SF-36 ) , and a patient 's global assessment of response to therapy ( PGART ) were measured at baseline , week 8 , and week 15 . Statistical analysis included all patients . RESULTS Four patients dropped out from each group . Both groups improved significantly at week 15 compared with baseline , with an average 36 % reduction in pain intensity . For PGART , 40 % of the DWR group and 30 % of the LBE group answered " much better " at posttreatment . FIQ total score and FIQ depression improvements in the DWR group were faster ( week 8) than the LBE group and kept improving ( week 15 ; P < 0.05 ) . Only the DWR group showed improvements in SF-36 role emotional ( P = 0.006 ) . No significant between-group differences were observed for peak oxygen uptake and other outcomes . CONCLUSION DWR is a safe exercise that has been shown to be as effective as LBE regarding pain . However , it has been shown to bring more advantages related to emotional aspects . Aerobic gain was similar for both groups , regardless of symptom improvement . Therefore , DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations OBJECTIVE To determine the most appropriate means to assess the response to treatment in terms of  pain and functional impairment in a chronic rheumatic condition ( knee osteoarthritis [ OA ] ) and an acute rheumatic condition ( rotator cuff syndrome [ RCS ] ) . METHODS Two prospect i ve studies were conducted consisting of 1,019 out patients with knee OA and 271 patients with acute RCS . The minimal clinical ly important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale , and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale ; for acute RCS pain , a numeral rating scale was used , and the Neer function subscale was used for RCS function . RESULTS The minimal clinical ly important improvement was shown to be the change required to achieve the patient acceptable symptom state , whatever the baseline level of symptom , the outcome ( pain or function ) , or type of condition ( chronic or acute ) . This acceptable state for pain was higher for chronic ( 27.0 - 36.4 across the baseline score ) than acute ( 16.7 - 24.1 ) conditions . The level of functional impairment considered satisfactory by patients with knee OA was higher for more disabled patients ( 43.1 ) than for less disabled patients ( 20.4 ) . CONCLUSION Patients consider that they experienced an important improvement only if this improvement allowed them to achieve a state they consider satisfactory . The most appropriate means to assess the response to therapy seems to be to assess whether patients feel good ( i.e. , achieve the patient acceptable symptom state ) PURPOSE Prostate biopsy for diagnosing cancer can be painful . Tramadol is a central ly acting analgesic used to treat many pain disorders . We determined whether administering oral tramadol and acetaminophen combined with 1 % lidocaine induced periprostatic nerve block would significantly decrease the pain experienced by patients during st and ard 10-core transrectal ultrasound guided needle biopsy of the prostate . MATERIAL S AND METHODS A total of 60 men who presented for diagnostic prostate biopsy were r and omized to receive placebo plus periprostatic 1 % lidocaine as the control group of 30 or 75 mg tramadol/650 mg acetaminophen orally plus periprostatic 1 % lidocaine as the experimental group of 30 before undergoing biopsy . Immediately after biopsy each patient was asked to rate the pain on a linear 10-point scale and a st and ard 6-point faces pain scale . Complications of pain medication administration in each group were noted and compared . RESULTS Pain medication administration was well tolerated by each study group except for lightheadedness/dizziness and itching in 1 patient each in the experimental group , and lightheadedness/dizziness in 1 patient in the control group . Overall patients in the experimental group reported a mean decrease + /- SD in the pain score of 2.3 + /- 2.4 on the scale of 1 to 10 ( p = 0.0008 ) and 1.11 + /- 1.25 on the scale of 0 to 5 compared with scores in controls ( p = 0.0009 ) . CONCLUSIONS Administering 75 mg tramadol/650 mg acetaminophen orally with periprostatic 1 % lidocaine before transrectal ultrasound guided prostate biopsy is a safe , easy and effective method of controlling pain during the biopsy procedure BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients BACKGROUND : Spinal fusion surgery causes severe postoperative pain , hampering reconvalescense . We investigated the efficacy of patient-controlled epidural analgesia ( PCEA ) in a prospect i ve , double-blind , r and omized , controlled comparison with patient-controlled IV analgesia ( PCIA ) . METHODS : After lumbar anterior-posterior fusion receiving an epidural catheter intraoperatively , 72 patients were given either PCEA ( ropivacaine 0.125 % and sufentanil 1.0 & mgr;g/mL at 14 mL/h ; bolus : 5 mL ; lockout time : 15 min ) and IV placebo or PCIA ( morphine 2.0 mg/mL ; bolus : 3 mg ; lockout time : 15 min ) and epidural placebo .  Pain levels ( visual analog scale 0 - 10 ) , functional capabilities ( turning in bed , st and ing , and walking ) , analgesic consumption , and side effects were evaluated until 72 h after surgery . RESULTS : Fourteen patients were excluded by predetermined criteria , leaving 58 patients for data analysis . Pain levels at rest and during mobilization were significantly lower in the PCEA when compared with that in the PCIA group throughout the study period ( P < 0.0001 in all cases ) . Time until able to turn in bed was achieved earlier in the PCEA group ( P < 0.05 ) . Patients in the PCEA group were significantly more satisfied with pain therapy ( P < 0.01 ) . CONCLUSION : We conclude that PCEA with ropivacaine and sufentanil , using intraoperatively placed epidural catheters , provides superior analgesia and higher patient satisfaction when compared with PCIA after spinal fusion surgery This r and omized , double-blind , placebo-controlled crossover study measured the effect of a single dose of oral gabapentin ( 900 mg ) on pain and allodynia associated with herpes zoster . Pain severity decreased by 66 % with gabapentin compared to 33 % with placebo . Reductions in allodynia area and severity , and overall pain relief , were also greater with gabapentin Objective : To study the effectiveness of intrauterine anesthesia for pain relief during fractional curettage . Methods : A double-blinded , r and omized , placebo-controlled trial was conducted in 66 patients with abnormal uterine bleeding undergoing fractional curettage under paracervical block , using 10-mL 1 % lidocaine plus intrauterine 5-mL 2 % lidocaine ( n = 33 ) or saline ( n = 33 ) . The primary outcome was the maximum pain score measured with a 10-cm visual analog scale . Other outcomes measured included pain profile , number of patients with pain score more than 4 , each patient 's global satisfaction index , adverse events , and serum lidocaine profile . Results : The 2 groups were comparable in age , body mass index , education , socioeconomic status , menopausal status , and parity . Compared with the saline group , the lidocaine group had a significantly lower median value for the maximum pain score ( 2.3 versus 4.7 , P = .022 ) and fewer patients with a pain score more than 4 ( 33.3 % versus 60.6 % , P = .026 ) . The pain scores were lower at the endocervical curettage and the uterine curettage steps . There was no difference between the 2 groups in other outcomes . The number needed to treat to prevent a case with a pain score more than 4 was 3.7 ( 95 % confidence interval 2.4–38.5 ) . Conclusion : The addition of intrauterine anesthesia to paracervical block can further reduce pain during fractional curettage without increasing adverse effects . Level of Evidence : Abstract Heat induced pain has been shown to follow a positively accelerating power function for groups of subjects , yet the extent to which this applies to individual subjects is unknown . Statistical methods were developed for assessing the goodness of fit and reliability of the power function for data from individual subjects with the aim of using such functions for characterizing individual differences in heat‐pain sensitivity . 175 subjects rated ascending and r and om series of contact heat stimuli  with visual analogue scales for pain intensity ( VAS‐I ) and unpleasantness ( VAS‐A ) . Curve fitting showed excellent model fit . Substitution of model estimates in place of observed VAS scores produced minimal bias in group means , about 0.3 VAS units in the ascending series and 1.0 in the r and om series , on a 0–100 scale . Individual power function exponents were considerably higher for the ascending than for the r and om series and somewhat higher for VAS‐A than for VAS‐I ( means : ascending VAS‐I=9.04 , VAS‐A=9.80 ; r and om VAS‐I=4.95 , VAS‐A=5.67 ) . The reliability of VAS estimates was high ( ≧.93 ) , and for the ascending series it remained so when extrapolating 4 ° C beyond the empirical range . Exponent reliability was high for the ascending series ( VAS‐I=.92 ; VAS‐A=.91 ) , but considerably lower for the r and om series ( VAS‐I=.69 ; VAS‐A=.71 ) . Individual differences constituted 60 % of the total variance in pain ratings , whereas stimulus temperature accounted for only 40 % . This finding underscores the importance of taking individual differences into account when performing pain studies STUDY OBJECTIVE We compare a st and ard weight-based dose of intravenous hydromorphone ( Dilaudid ) to a st and ard weight-based dose of intravenous morphine in adults presenting to the ED with acute severe pain . METHODS This was a prospect i ve , r and omized , double-blind , clinical trial conducted in an academic medical center . Of the 198 adult patients presenting to the ED with acute severe pain who were r and omized to receive either intravenous hydromorphone at 0.015 mg/kg or intravenous morphine at 0.1 mg/kg , 191 patients had sufficient data for analysis . The main outcome measure was the difference between the 2 groups in pain reduction at 30 minutes as measured on a vali date d numeric rating scale . Adverse effects , pain reduction at 5 minutes and 2 hours postbaseline , and additional analgesics and antiemetics were tracked as secondary outcome measures . RESULTS The mean change of pain from baseline to 30 minutes postbaseline in patients allocated to intravenous hydromorphone was -5.5 numeric rating scale units versus -4.1 in patients allocated to intravenous morphine ( difference -1.3 ; 95 % confidence interval -2.2 to -0.5 ) . Adverse effects were similar in both groups , with the exception of pruritus , which did not occur in patients receiving hydromorphone ( 0 % versus 6 % [ difference -6 % ; 95 % confidence interval -11 % to -1 % ] ) . No patient required naloxone . CONCLUSION For the treatment of acute , severe pain in the emergency department , intravenous hydromorphone at 0.015 mg/kg represents a feasible alternative to intravenous morphine at 0.1 mg/kg
target: Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
background: OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .