## Protocol Section
### Identification Module
**NCT ID:** NCT01583179

**Brief Title:** Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution

**Official Title:** Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution

#### Organization Study ID Info
**ID:** 2011-0781
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
#### Secondary ID Infos
**Domain:** UW, Madison
**ID:** SMPH/ANESTHESIO
**Type:** OTHER
**Domain:** UW, Madison
**ID:** A530900
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-09-11

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-10

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-09-11

**Type:** ACTUAL

**Results First Submit Date:** 2019-08-19

**Results First Submit QC Date:** 2019-09-10

#### Start Date
**Date:** 2012-04

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2012-04-23
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-19
**Study First Submit QC Date:** 2012-04-19
**Why Stopped:** The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Wisconsin, Madison

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.

### Conditions Module

**Conditions:**

- Regional Block for Pain Control

- Supraclavicular Block

- Ultrasound Guided Block

- Block Additive

**Keywords:**

- nerve block

- outpatient surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** will get only local anesthetic and epinephrine in block. no additive in block

**Label:** Control group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

**Intervention Names:**

- Drug: Buprenorphine

**Label:** buprenorphine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- buprenorphine

**Description:** added to nerve block, 0.3mg one time peripheral block use

**Name:** Buprenorphine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Time in minutes until first pain medication was take by participant post-operatively

**Measure:** Time Until First Pain Medication Post-operatively

**Time Frame:** 48 hrs

#### Secondary Outcomes

**Description:** pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be)

**Measure:** Pain Score on Post Operative Day 1

**Time Frame:** 1 day postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3
2. Age 18-79, inclusive
3. BMI \<36 kg/m\^2
4. Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure

Exclusion Criteria:

1. Patients with coagulation disorders
2. Clinically significant pulmonary disease
3. Clinically significant cardiac disease
4. Neurologic deficit in surgical extremity
5. Allergy to bupivacaine or buprenorphine
6. Intolerance of narcotics
7. Local infection over intended area of needle insertion
8. Hepatic failure or renal failure
9. Significant psychiatric disease, including drug abuse
10. Seizure disorder
11. Possible pregnancy or lactation by patient report
12. Use of narcotic medication greater than 2 times a week for greater than 1 week.
13. Patients for whom the surgeon requests a shorter-acting block

**Maximum Age:** 79 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin

**State:** Wisconsin

**Zip:** 53705

#### Overall Officials

**Official 1:**

**Affiliation:** University of Wisconsin School of Medicine and Public Health, Madison

**Name:** Melanie Donnelly, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000009292

- Term: Narcotic Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Analg

- Name: Analgesics

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M7992

- Name: Epinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M5317

- Name: Buprenorphine

- Relevance: HIGH

- As Found: Aortic

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M12243

- Name: Narcotic Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002047

- Term: Buprenorphine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse events were not monitored. The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment

#### Event Groups

**Group ID:** EG000

**Title:** Control Group

**Description:** will get only local anesthetic and epinephrine in block. no additive in block

**ID:** EG000

**Title:** Control Group

**Group ID:** EG001

**Title:** Buprenorphine

**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use

**ID:** EG001

**Title:** Buprenorphine

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 12

**Group ID:** BG002

**Value:** 26

**Units:** Participants

### Group

**ID:** BG000

**Title:** Control Group

**Description:** will get only local anesthetic and epinephrine in block. no additive in block

### Group

**ID:** BG001

**Title:** Buprenorphine

**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** 20-29

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** 30-39

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** 40-49

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** 50-59

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** 60-69

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** 70-79

**Class Title:** Age of participants

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** melanie.donnelly@ucdenver.edu
**Organization:** University of Wisconsin-Madison
**Phone:** 720-848-0000
**Title:** Melanie Donnelly
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 250
- **Upper Limit:** 
- **Value:** 965
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 311
- **Upper Limit:** 
- **Value:** 862
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.25
- **Spread:** 
- **Upper Limit:** 7.75
- **Value:** 6.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.75
- **Spread:** 
- **Upper Limit:** 8.25
- **Value:** 4.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Time in minutes until first pain medication was take by participant post-operatively
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment.The Overall Number of Participants Analyzed represents the Number of Participants with evaluable data.
**Reporting Status:** POSTED
**Time Frame:** 48 hrs
**Title:** Time Until First Pain Medication Post-operatively
**Type:** PRIMARY
**Unit of Measure:** Time in minutes
##### Group
**Description:** will get only local anesthetic and epinephrine in block. no additive in block
**ID:** OG000
**Title:** Control Group
##### Group
**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
**ID:** OG001
**Title:** Buprenorphine
#### Outcome Measure 2
**Description:** pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be)
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
**Reporting Status:** POSTED
**Time Frame:** 1 day postoperative
**Title:** Pain Score on Post Operative Day 1
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** will get only local anesthetic and epinephrine in block. no additive in block
**ID:** OG000
**Title:** Control Group
##### Group
**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
**ID:** OG001
**Title:** Buprenorphine
### Participant Flow Module
#### Group
**Description:** will get only local anesthetic and epinephrine in block. no additive in block
**ID:** FG000
**Title:** Control Group
#### Group
**Description:** will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
**ID:** FG001
**Title:** Buprenorphine
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Screen failure
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True