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Early Post-Operative Pain Control Following Wrist Operations

NCT ID: NCT02052180

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

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.

Control

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

Group Type ACTIVE_COMPARATOR

Marcaine (Control)

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason P. Rehm, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee College of Medicine Chattanooga

Locations

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UTCOM Chattanooga Department of Plastic Surgery

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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BVM-3-27

Identifier Type: -

Identifier Source: org_study_id