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Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control

NCT04897841 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-22

Study results available
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Summary

This study seeks to identify whether the addition of liposomal bupivacaine to regular bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled and can be expect to be on study for up to 6 weeks post-partum.

Conditions

  • Cesarean Section Complications
  • Pain
  • Opioid Use

Interventions

DRUG

Liposomal bupivacaine

20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.

DRUG

Bupivacaine Hydrochloride

30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic

OTHER

saline

post-surgical saline

Sponsors & Collaborators

  • Meriter Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Kathleen M Antony, MD, MSCI · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-08-31
Completion
2022-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04897841 on ClinicalTrials.gov