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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:
ClinicalTrials.gov Identifier:
NCT01583179
First Posted: April 23, 2012
Last Update Posted: January 8, 2016
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
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

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 ]

Secondary Outcome Measures:
  • pain score postoperatively on POD1 [ Time Frame: 24 hrs ]

Enrollment: 22
Study Start Date: April 2012
Study Completion Date: December 2015
Primary Completion Date: March 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01583179


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01583179     History of Changes
Other Study ID Numbers: 2011-0781
First Submitted: April 19, 2012
First Posted: April 23, 2012
Last Update Posted: January 8, 2016
Last Verified: January 2016

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

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