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Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial

NCT04680221 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-03-25

No results posted yet for this study

Summary

As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.

Conditions

  • Pain, Postoperative
  • Opioid Use

Interventions

DRUG

Liposomal bupivacaine

Deposition of liposomal bupivacaine

PROCEDURE

TAP block

Transversus abdominis plane block performed to deposit anesthetic

DRUG

Deposition of saline

Deposition of saline

Sponsors & Collaborators

  • Truman Medical Center

    collaborator OTHER

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Devika Maulik, MD · Children's Mercy Hospital Kansas City

  • Gary Sutkin, MD · University of Missouri, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-06-01
Completion
2025-06-01
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 NCT04680221 on ClinicalTrials.gov