Early Post-Operative Pain Control Following Wrist Operations

Not Applicable

• Conditions: Pain
• Interventions: Drug: Marcaine (Control); Drug: Exparel

• Registration Number: NCT02052180
• Lead Sponsor: University of Tennessee

Brief Summary

The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age > 18 years
• ASA physical status 1-3
• Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
• Physically and mentally able to participate in the study and complete all study assessments
• Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.

Exclusion Criteria

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
• Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
• Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
• Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
• Confirmed pregnancy at time of enrollment
• Patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Marcaine (Control)	15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
Exparel	Exparel	EXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures.

Primary Outcome Measures

Name	Time	Method
Changes in Pain	Pre-op, Post-op days: 1,2,3,4, and 14	Pain measured by Numeric Rating Scale (NRS)

Trial Locations

Locations (1)

UTCOM Chattanooga Department of Plastic Surgery; 🇺🇸 Chattanooga, Tennessee, United States