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Rectus Sheath Block for Analgesia After Gynecological Laparotomy

NCT06575699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-02

No results posted yet for this study

Summary

Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.

Conditions

  • Gynecologic Surgical Procedures

Interventions

DRUG

Bupivacaine-Hydromorphone Cassette

Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution

PROCEDURE

Rectus sheath block

bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side deposited between the rectus abdomens muscle and the posterior rectus sheath.

PROCEDURE

Thoracic Epidural Analgesia

Low thoracic Epidural Analgesia.

DRUG

Liposomal bupivacaine

133 mg liposomal bupivacaine per side for rectus sheath block

DRUG

Bupivacaine Hydrochloride

20 mL bupivacaine 0.25% per side for rectus sheath block

Sponsors & Collaborators

Principal Investigators

  • Ashraf Habib, M.D. · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-11-28
Completion
2025-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06575699 on ClinicalTrials.gov