Early Post-Operative Pain Control Following Wrist Operations

Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02052180

Enrollment

Registered

2014-01-31

Start date

2013-05-31

Completion date

2014-05-31

Last updated

2014-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine

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.

Interventions

DRUGExparel

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.

DRUGMarcaine (Control)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026