Early Post-Operative Pain Control Following Wrist Operations

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Exparel
* Drug: Marcaine (Control)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel<br>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. | Drug: Exparel<br>* 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.<br>|
| Active Comparator: Control<br>15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice. | Drug: Marcaine (Control)<br>* 15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine