Early Post-Operative Pain Control Following Wrist Operations

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02052180
• Other study ID #: BVM-3-27
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 30, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UTCOM Chattanooga Department of Plastic Surgery	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pain	Pain measured by Numeric Rating Scale (NRS)	Pre-op, Post-op days: 1,2,3,4, and 14	No