NCT02052180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

January 22, 2014

Last Update Submit

January 30, 2014

Conditions

Pain

Keywords

Carpalmetacarpal arthroplastyProximal row carpectomyPost-operative pain controlExparelMarcaine

Outcome Measures

Primary Outcomes (1)

  • Changes in Pain

    Pain measured by Numeric Rating Scale (NRS)

    Pre-op, Post-op days: 1,2,3,4, and 14

Study Arms (2)

Exparel

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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)

Interventions

ExparelDRUG

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.

Exparel
Marcaine (Control)DRUG

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTCOM Chattanooga Department of Plastic Surgery

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jason P. Rehm, MD

    University of Tennessee College of Medicine Chattanooga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 31, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(1)