Comparison of Bupivacaine and Exparel for Carpal Tunnel Release

Pain After Carpal Tunnel Release Clinical Trial

Official title:

Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02141178
• Other study ID #: PRO14040418
• Status: Withdrawn
• Phase: N/A
• First received: May 12, 2014
• Last updated: January 4, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.

The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients with carpal tunnel syndrome undergoing surgery

Exclusion Criteria:

• Non english speaking

• Allergy to bupivacaine or exparel

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pain After Carpal Tunnel Release

Intervention

Drug:
• Bupivacaine

• Exparel

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain will be evaluated using an 11-point ordinal scale (0-10)	Starting immediately after surgery and then every 8 hours for 10 days	No