NCT02141178

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

May 12, 2014

Last Update Submit

January 4, 2016

Conditions

Pain After Carpal Tunnel Release

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Patients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery

Drug: Bupivacaine

Exparel

EXPERIMENTAL

Patients will received Exparel subcutaneously for local anesthesia during surgery

Drug: Exparel

Interventions

BupivacaineDRUG
Bupivacaine
ExparelDRUG
Exparel

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with carpal tunnel syndrome undergoing surgery

You may not qualify if:

  • Non english speaking
  • Allergy to bupivacaine or exparel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 19, 2014

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

US(1)