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

This study is currently recruiting participants.
Verified April 2012 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
Melanie Donnelly, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01583179
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Regional Block for Pain Control
Supraclavicular Block
Ultrasound Guided Block
Block Additive
 Drug: Buprenorphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Time to first pain medication [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain score postoperatively on POD1 [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583179

Contacts
Contact: melanie j donnelly 608-263-8100

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: melanie j donnelly, md     608-263-8100        
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Melanie Donnelly, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01583179     History of Changes
Other Study ID Numbers: H-2011-0781
Study First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
nerve block
outpatient surgery

Additional relevant MeSH terms:
Analgesics
Buprenorphine
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Analgesics, Opioid
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013