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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583179
Recruitment Status : Terminated (The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment)
First Posted : April 23, 2012
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Regional Block for Pain Control Supraclavicular Block Ultrasound Guided Block Block Additive Drug: Buprenorphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

Primary Outcome Measures :
  1. Time Until First Pain Medication Post-operatively [ Time Frame: 48 hrs ]
    Time in minutes until first pain medication was take by participant post-operatively

Secondary Outcome Measures :
  1. Pain Score on Post Operative Day 1 [ Time Frame: 1 day postoperative ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583179

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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Melanie Donnelly, MD University of Wisconsin School of Medicine and Public Health, Madison
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01583179    
Other Study ID Numbers: 2011-0781
SMPH/ANESTHESIO ( Other Identifier: UW, Madison )
A530900 ( Other Identifier: UW, Madison )
First Posted: April 23, 2012    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by University of Wisconsin, Madison:
nerve block
outpatient surgery
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists