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

NCT01583179 | Terminated Results

• 3 other identifiers: 2011-0781SMPH/ANESTHESIOA530900
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Regional Block for Pain Control; Supraclavicular Block; Ultrasound Guided Block; Block Additive

Keywords

nerve block; outpatient surgery

Outcome Measures

Primary Outcomes (1)

• Time Until First Pain Medication Post-operatively

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

  48 hrs

Secondary Outcomes (1)

• Pain Score on Post Operative Day 1

  1 day postoperative

Study Arms (2)

Control group

NO INTERVENTION

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

buprenorphine

EXPERIMENTAL

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

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

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

buprenorphine

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Melanie Donnelly
• Organization: University of Wisconsin-Madison

melanie.donnelly@ucdenver.edu

720-848-0000

Study Officials

• Melanie Donnelly, MD

  University of Wisconsin School of Medicine and Public Health, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-09

Locations

US (1)