Comparison of Bupivacaine and Exparel for Carpal Tunnel R... | NCT02141178

Studies
Comparison of Bupivacaine and Exparel for Carpal Tunnel Release

NCT02141178

Sponsor

University of Pittsburgh

Status

Withdrawn

Last Update Posted

Jan 5, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pain After Carpal Tunnel Release

Interventions

Bupivacaine
Exparel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No IRB approval

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 12, 2014

First Submission Date that Met QC Criteria

May 14, 2014

First Posted Date

May 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2016

Last Update Posted Date

Jan 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug		Bupivacaine
Exparel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with carpal tunnel syndrome undergoing surgery

Exclusion Criteria:

Non english speaking
Allergy to bupivacaine or exparel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided