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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Melanie Donnelly, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01583179
First received: April 19, 2012
Last updated: August 6, 2014
Last verified: December 2013
  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:


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 ]

Enrollment: 26
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583179

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
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: 2011-0781
Study First Received: April 19, 2012
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014