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Early Post-Operative Pain Control Following Wrist Operations

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exparel
Marcaine (Control)
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UTCOM Chattanooga Department of Plastic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exparel

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Changes in Pain
Pain measured by Numeric Rating Scale (NRS)

Secondary Outcome Measures

Full Information

First Posted
January 22, 2014
Last Updated
January 30, 2014
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02052180
Brief Title
Early Post-Operative Pain Control Following Wrist Operations
Official Title
Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exparel
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Marcaine (Control)
Intervention Description
15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
Primary Outcome Measure Information:
Title
Changes in Pain
Description
Pain measured by Numeric Rating Scale (NRS)
Time Frame
Pre-op, Post-op days: 1,2,3,4, and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason P. Rehm, MD
Organizational Affiliation
University of Tennessee College of Medicine Chattanooga
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTCOM Chattanooga Department of Plastic Surgery
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

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Early Post-Operative Pain Control Following Wrist Operations

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