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Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

NCT03250507 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-12-21

Study results available
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Summary

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Conditions

  • Hysterectomy

Interventions

DRUG

Bupivacaine

0.25% bupivacaine for TAP block

DRUG

Liposomal bupivacaine

Exparel for TAP block

DRUG

Saline

Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Mohamed-Rida Alsaden, MBChB FRCPC · Henry Ford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2019-01-30
Completion
2019-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03250507 on ClinicalTrials.gov