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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01583179
Other study ID # 2011-0781
Secondary ID SMPH/ANESTHESIOA
Status Terminated
Phase N/A
First received
Last updated
Start date April 2012
Est. completion date December 2015

Study information

Verified date September 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date December 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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

Study Design


Intervention

Drug:
Buprenorphine
added to nerve block, 0.3mg one time peripheral block use

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time Until First Pain Medication Post-operatively Time in minutes until first pain medication was take by participant post-operatively 48 hrs
Secondary Pain Score on Post Operative Day 1 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) 1 day postoperative
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02383134 - Maximal Distance for Successful Supraclavicular Block N/A