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Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

NCT02179892 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-08-11

Study results available
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Summary

The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown.

The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

Conditions

Interventions

DRUG

Bupivacaine Extended-Release Liposome Injection (Exparel)

266mg/30mL of Exparel will be injected via unilateral TAP block

DRUG

Bupivacaine and Dexamethasone Injection

As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.

DRUG

IV Acetaminophen

Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.

DRUG

Oral Acetaminophen

Oral acetaminophen 650 mg every 6 hours.

Sponsors & Collaborators

  • Colette Curtis MD

    lead OTHER

Principal Investigators

  • Colette Curtis, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-06
Completion
2015-06-06

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179892 on ClinicalTrials.gov