[Cryotherapy as analgesic technique in direct, postoperative treatment following elective joint replacement]. Continuous-flow cold therapy after total knee arthroplasty. Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study. Laser or cryotherapy for cervical intraepithelial neoplasia: a randomized study to compare efficacy and side effects. Combination of acute preoperative plateletpheresis, cell salvage, and aprotinin minimizes blood loss and requirement during cardiac surgery. The effect of heated humidified carbon dioxide on postoperative pain, core temperature, and recovery times in patients having laparoscopic surgery: a randomized controlled trial. The efficacy and safety of aprotinin for hemostasis during intracranial surgery. Postoperative aprotinin: effect on blood loss and transfusion requirements in cardiac operations. Effects of low central venous pressure during preanhepatic phase on blood loss and liver and renal function in liver transplantation. Does cryosupernatant plasma improve outcome in thrombotic thrombocytopenic purpura? No answer yet. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. The efficacy of antifibrinolytics in the reduction of blood loss during complex adult reconstructive spine surgery.
The application of crushed ice or hydrogenated silicate, a micro-crystalline substitute has been used as a method to treat posttraumatic and postoperative irritations of the locomotor system for a long time. Closed systems using pumps can be viewed as further development as they enable continuous, water-free cooling of operating areas. The analgetic effect of postoperative cold therapy was evaluated in a prospective clinical trial, including 312 patients after total knee or hip arthroplasty. Conventional cold packs, consisting of microcrystalline silicate were compared to a continuous applicable closed system. Continuous cryotherapy resulted in a depression of skin temperature to 12 degrees C, whereas intermittent cooling only caused a mean temperature decrease of 1 degree C. Clinically continuous cold application leads to a more than 50% decrease of analgetic demands in both, systemic and regional application (p < 0.001). This observation was found in a significant correlation with patient's pain sensation as well as primary range of motion. Intermittent cryotherapy was found to be ineffective in postoperative pain relieve in hip- and adequate in knee arthroplasty patients. We could not report an influence on postoperative blood loss, as discussed in previous reports. Cryotherapy is widely used as an emergency treatment of sports trauma and postoperatively especially after anterior cruciate ligament reconstruction. Studies in the literature on the effect of cryotherapy after total knee arthroplasty (TKA) have been limited and controversial. In this prospective study, 60 primary TKAs were done on 30 patients (all staged bilateral TKAs). For every patient, 1 TKA had a continuous-flow cooling device applied over the surgical dressing immediately postoperatively. The other TKA in the same patient (control TKA) was done 6 weeks later and had no cooling device. The study compared the range of motion, the volume of hemovac output and blood loss, visual analog pain score, analgesic consumption, and wound healing in the 2 limbs of the same patient. This study showed that continuous-flow cold therapy is advantageous after TKA because it provides better results in all the areas compared.
                Copyright 2002, Elsevier Science (USA). To assess the efficacy and safety of Insuflow (Georgia BioMedical, Inc.) filter heater hydrator device in reducing the incidence, severity and extent of hypothermia, length of recovery room stay and postoperative pain at the time of laparoscopy.
                Prospective, randomized, blinded, controlled multi-center study. Patients underwent gynecologic procedures via laparoscopy; surgeons, anesthesiologists and recovery room personnel assessed the results.
                Seven North American institutions.
                Seventy-two women for safety evaluation and efficacy studies.
                Intraoperative pre-conditioning of laparoscopic gas with the Insuflow device (treatment) or standard raw gas (control) during laparoscopic surgery and postoperatively.
                Incidence, severity and extent of hypothermia, postoperative pain perception and length of recovery room stay.
                The Insuflow group had significantly less intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain. Pre-conditioning of laparoscopic gas by filtering heating and hydrating was well tolerated with no adverse effects. The safety profile of the Insuflow pre-conditioned gas showed significant benefits compared to currently used raw gas.
                Pre-conditioning laparoscopic gas by filtering heating and hydrating with the Insuflow device was significantly more effective than the currently used standard raw gas and was safe in reducing or eliminating laparoscopic-induced hypothermia, shortening recovery room length of stay and reducing postoperative pain. A randomized study was performed to compare efficacy and side effects of laser and cryotherapy: 51 patients were treated with laser vaporization and 50 patients with cryotherapy. Success rates for laser and cryotherapy were not significantly different. Success rates were significantly related to lesion size. Grade of CIN, positive endocervical curettage, parity, and age at treatment were not found to be related. Vaginal discharge, both in duration and amount, was significantly less in patients treated with laser vaporization, compared with cryotherapy, but pain and bleeding occurred more often in patients treated with laser vaporization. A brief review of possible sources of bias in comparative studies on laser and cryotherapy is given, indicating the preference for a randomized study. It is concluded that widespread introduction of laser facilities in smaller centers is not justified, because the success rates are not better than those of cryotherapy, and because the advantages of less discharge are outweighed by the high cost. Acute preoperative plateletpheresis (APP), cell salvage (CS) technique, and the use of aprotinin have been individually reported to be effective in reducing blood loss and blood component transfusion while improving hematological profiles in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). In this prospective randomized clinical study, the efficacy of these combined approaches on reducing blood loss and transfusion requirements was evaluated. Seventy patients undergoing primary coronary artery bypass grafting (CABG) were randomly divided into four groups: a control group (group I, n = 10) did not receive any of the previously mentioned approaches. An APP and CS group (group II, n = 20) experienced APP in which preoperative platelet-rich plasma was collected and reinfused after reversal of heparin, along with the cell salvage technique throughout surgery. The third group (group III, n = 22) received aprotinin in which 5,000,000 KIU Trasylol was applied during surgery, and a combination group (group IV, n = 18) was treated with all three approaches, i.e., APP, CS, and aprotinin. Compared with group I (896+/-278 mL), the postoperative total blood loss was significantly reduced in groups II, III, and IV (468+/-136, 388+/-122, 202+/-81 mL, respectively, p < 0.05). The requirements of packed red blood cells in the three approached groups (153+/-63, 105+/-178, 0+/-0 mL, respectively) also were reduced when compared with group I (343+/-118 mL, p < 0.05). In group I, six patients (6/10) received fresh-frozen plasma and three patients (3/10) received platelet transfusion, whereas no patients in the other three groups required fresh-frozen plasma and platelet. In conclusion, both plateletpheresis concomitant with cell salvage and aprotinin contribute to the improvement of postoperative hemostasis, and the combination of these two approaches could minimize postoperative blood loss and requirement. To determine whether use of heated humidified carbon dioxide as insufflation gas during gynecologic laparoscopy reduced postoperative pain and hypothermia.
                A randomized controlled trial (Canadian Task Force classification 1).
                A tertiary referral hospital.
                Sixty women scheduled for gynecologic laparoscopy between 30 and 90 minutes' duration.
                Operative laparoscopic management of endometriosis, adhesions, or adnexal pathology.
                Sixty patients were randomized into either receiving heated humidified carbon dioxide (study group) or standard cold dry gas (control group). Intraoperative and postoperative core temperature, total analgesic use, postoperative nausea, and recovery room time were recorded. Postoperative pain intensity was assessed using visual analog scale. Statistical analysis was performed using software. No significant difference was revealed between groups with regard to postoperative pain, analgesic requirements, recovery room time, or postoperative nausea. The control group had less postoperative hypothermia, suggesting that external warming blankets may be more effective than heated humidified gas at maintaining intraoperative normothermia.
                The use of heated humidified carbon dioxide insufflation for short-duration gynecologic laparoscopy up to 90 minutes' duration was not associated with any significant benefit with regard to postoperative pain, hypothermia, or time of recovery room stay. The aim of this study was to determine the safety and efficacy of prophylactic high-dose intravenous aprotinin in reducing intraoperative blood loss in the neurosurgical population.
                A randomized, double-blind, placebo-controlled trial was conducted in parallel groups in two regional neurosurgical departments. One hundred patients with a preoperative diagnosis of intracranial meningioma or vestibular schwannoma subsequently confirmed on histological studies were included. All patients were older than 18 years of age, pregnancy had been excluded, there was no history of bleeding diathesis, no previous exposure to aprotinin, and no ingestion of antiplatelet or anticoagulant medications within the 2 weeks preceding surgery. Aprotinin was administered in doses of 30,000 kallikrein-inhibiting units (KIU)/kg body weight on induction of anesthesia and was continued as an infusion of 10,000 KIU/kg/hr until surgery was complete, or for a maximum of 8 hours. Intraoperative blood loss, blood transfusion, the Glasgow Outcome Scale score, and the Index of Independence were measured, and screening for deep vein thrombosis and the Mini-Mental State Examination were performed.
                Intraoperative blood loss was reduced from 1014 ml (geometric mean) to 508 ml (p = 0.028). Although this study was not designed to evaluate the need for blood transfusion, 37 U of blood was used in 11 patients in the aprotinin group and 58 U in 13 patients in the placebo group (not significant). There were no significant differences in postoperative thrombotic risk or other outcome measures between treatment groups. Aprotinin therefore can be safely used to reduce intraoperative blood loss in patients who are not receiving anticoagulation therapy. Aprotinin has been used increasingly to reduce postoperative blood loss in open heart operations. Although it was reported as safe in earlier studies, the overall safety of prophylactic use has been questioned recently. Because of the potential for complications and the high cost, it will be reasonable to use aprotinin more selectively in the postoperative period.
                We prospectively studied the effect of postoperative low-dose aprotinin (2 million kallikrein inactivator units [280 mg]) on blood loss and transfusion requirements in patients undergoing cardiopulmonary bypass. Seventy-five patients were randomly assigned to three groups: prophylactic high-dose aprotinin (group 1), postoperative aprotinin (group 2), or a nonmedicated control group (group 3).
                The three groups were comparable in all demographic and operative variables. Postoperative chest tube drainage was significantly decreased in both aprotinin groups compared with that in the control group (295 mL in group 1 and 325 mL in group 2 versus 411 mL in group 3; p < 0.05). No significant difference was seen between the two aprotinin groups. The use of homologous blood products was significantly less in group 1 and group 2 than in group 3 (1.15 +/- 1.13 U and 1.35 +/- 1.30 U versus 2.55 +/- 1.09 U; p < 0.05).
                Our results suggest that postoperative aprotinin reduces blood loss and transfusion requirements comparably with prophylactic high-dose aprotinin. Thus, one can restrict its use to patients with excessive postoperative bleeding. Although the low central venous pressure (LCVP) technique is used to decrease blood loss during liver resection, its efficacy and safety during transplant procedures are still debatable. Our study aimed to assess the effects of this technique and its clinical safety for recipients undergoing liver transplantation.
                Eighty-six adult patients were randomly divided into a LCVP group and a control group. In the LCVP group, CVP was maintained below 5 mmHg or 40% lower than baseline during the preanhepatic phase by limiting infusion volume, manipulating the patient's posture, and administration of somatostatin and nitroglycerine. Recipients in the control group received standard care. Hemodynamics, blood loss, liver function, and renal function of the two groups were compared perioperatively.
                A lower CVP was maintained in the LCVP group during the preanhepatic phase, resulting in a significant decrease in blood loss (1922 +/- 1429 vs. 3111 +/- 1833 ml, P < 0.05) and transfusion volume (1200 +/- 800 vs. 2400 +/- 1200 ml, P < 0.05) intraoperatively. Compared with the control group, the LCVP group had a significantly lower mean arterial pressure at 2 h after the start of the operation (74 +/- 11 vs. 84 +/- 14 mmHg, P < 0.05), a lower lactate value at the end of the operation (5.9 +/- 3.0 vs. 7.2 +/- 3.0 mmol/l, P < 0.05), and a better preservation of liver function after the declamping of the portal vein. There were no significant differences in perioperative renal function and postoperative complications between the groups.
                The LCVP technique during the preanhepatic phase reduced intraoperative blood loss, protected liver function, and had no detrimental effects on renal function in LT. A randomized prospective trial compared cryosupernatant plasma (CSP) to fresh frozen plasma (FFP) for treatment of thrombotic thrombocytopenic purpura (TTP). A total of 236 patients were required: 28 patients were treated with CSP and 24 with FFP within 30 months. There were no differences in survival at 1 month. By day 9, 17 of 26 patients with CSP and 18 of 24 with FFP had a platelet count >100 x 10(9)/l. At entry, von Willebrand factor (VWF) multimers were normal in all patients (range 1.1-3.95 IU/ml). ADAMTS-13 levels showed large variations ranging from 10% to 100% activity. At entry, no individual had <5% VWF cleaving protease. By day 9 (end of cycle), 89% (FFP) and 67% (CSP) had levels >50% of the controls. At 6 months some patients showed inhibitors to the enzyme in spite of adequate or normal platelet counts. The data from this study do not show an apparent advantage to the use of CSP in TTP. A large number of patients will be required to determine appropriate replacement therapy. We were not able to find a statistically significant relationship between the low level of protease activity at presentation of TTP and response. Forty patients with multiple myeloma scheduled to receive melphalan 200 mg/m(2) followed by autologous stem cell transplantation were randomly assigned to receive oral cryotherapy or room temperature normal saline rinses 30 min before and for 6 h after high-dose therapy. Patients were evaluated for the development of mucositis using the National Cancer Institute grading system as well as evaluation of secondary measures such as days of total parenteral nutrition (TPN), narcotic use, hospitalization, weight loss and resumption of oral caloric intake for 28 days after transplant. Patients self-scored their pain, swallowing, drinking, eating, sleeping and taste alterations for 28 days. The primary end point of this trial was the incidence of grades 3-4 mucositis. Compared to the normal saline group, patients using cryotherapy experienced less grade 3-4 mucositis, 14 vs 74%, P=0.0005. Patients receiving cryotherapy also had statistically lower uses of narcotics and TPN, although there were no differences in length of hospitalization or weight loss. Patient-reported pain was significantly lower and activities were significantly better in the cryotherapy group. Controlled study to assess the efficacy of aprotinin and Amicar in reducing blood loss during complex spinal fusions.
                To compare blood loss and the clotting profile with a thromboelastogram in patients with spinal deformities undergoing sequential anterior and posterior spinal fusions treated intraoperatively with either aprotinin or Amicar.
                Spinal fusion for correction of adult spinal deformities is associated with large blood losses despite the implementation of multiple factors to reduce this blood loss. The antifibrinolytics aprotinin and Amicar have both been shown to reduce blood loss in other surgical procedures with the potential for large blood loss. Hence, we compared their efficacy for reducing blood loss in complex spinal fusions.
                Sixty patients for elective sequential anteroposterior thoracolumbosacral fusions were randomly assigned to three groups: control, aprotinin, and Amicar. Patients were assessed for blood loss, transfusion requirements, postoperative complications, and coagulation profile using a thromboelastogram.
                The study demonstrated a significant reduction in total blood loss (aprotinin 3628 mL, Amicar 4056 mL, control 5181 mL) and transfusion requirements using the half-dose aprotinin regimen compared with Amicar or control. Aprotinin also preserved the thromboelastogram mean clot formation time, clot strength, and clotting index compared with Amicar or control.
                For complex spinal operations with large blood losses, the half-dose aprotinin regimen will reduce blood loss and the need for blood components and may have a role in reducing postoperative lung injury.
Potential benefits of cryotherapy on blood loss, postoperative pain, and range of motion may be too small to justify its use, and the quality of the evidence was very low or low for all main outcomes. This needs to be balanced against potential inconveniences and expenses of using cryotherapy. Well designed randomised trials are required to improve the quality of the evidence.