Early Post-Operative Pain Control Following Wrist Operations

University of Tennessee

Status: Unknown

Conditions: Pain

Treatments: Drug: Exparel; Drug: Marcaine (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT02052180

BVM-3-27

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Exparel

Experimental group

Description:

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.

Treatment:

Drug: Exparel

Control

Active Comparator group

Description:

15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.

Treatment:

Drug: Marcaine (Control)