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

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.

Study Overview

• Status: Terminated
• Conditions: Regional Block for Pain Control; Supraclavicular Block; Ultrasound Guided Block; Block Additive
• Intervention / Treatment: Drug: Buprenorphine

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; will get only local anesthetic and epinephrine in block. no additive in block
Experimental: buprenorphine; will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block	Drug: Buprenorphine; added to nerve block, 0.3mg one time peripheral block use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Until First Pain Medication Post-operatively	Time in minutes until first pain medication was take by participant post-operatively	48 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score on Post Operative Day 1	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)	1 day postoperative

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Melanie Donnelly, MD, University of Wisconsin School of Medicine and Public Health, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 23, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: nerve block; outpatient surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 2011-0781; A530900 (Other Identifier: UW Madison); SMPH/ANESTHESIO (Other Identifier: UW, Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No