Rectus Sheath Block for Analgesia After Gynecological Laparotomy

NCT06575699 | Completed Phase 4 FDA Drug

• 1 other identifier: Pro00115981
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption 0- 72 hours after surgery

  0-72 hours after time 0 (end of surgery)

Secondary Outcomes (14)

• Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours

  0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)

• Number of patients with intraoperative hypotension

  Intraoperative

• Number of patients with postoperative hypotension

  0-72 hours after time 0 (end of surgery)

• Number of patients receiving rescue antiemetics

  0-72 hours after time 0 (end of surgery)

• Number of patients receiving rescue antipruritics

  0-72 hours after time 0 (end of surgery)

Other Outcomes (1)

• Complications related to rectus sheath block or epidural analgesia

  0-72 hours after time 0 (end of surgery)

Study Arms (2)

Rectus Sheath Block Group (Prospective arm)

EXPERIMENTAL

Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.

Procedure: Rectus sheath block; Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Thoracic Epidural Analgesia Group (retrospective arm)

ACTIVE COMPARATOR

60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h.

Procedure: Thoracic Epidural Analgesia; Drug: Bupivacaine-Hydromorphone Cassette

Interventions

Thoracic Epidural Analgesia PROCEDURE

Low thoracic Epidural Analgesia.

Thoracic Epidural Analgesia Group (retrospective arm)

Liposomal bupivacaine DRUG

133 mg liposomal bupivacaine per side for rectus sheath block

Rectus Sheath Block Group (Prospective arm)

Bupivacaine Hydrochloride DRUG

20 mL bupivacaine 0.25% per side for rectus sheath block

Rectus Sheath Block Group (Prospective arm)

Bupivacaine-Hydromorphone Cassette DRUG

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

Thoracic Epidural Analgesia Group (retrospective arm)

Rectus sheath block PROCEDURE

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.

Rectus Sheath Block Group (Prospective arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
• ASA Classification II or III.
• English speaking patients

You may not qualify if:

• BMI \>50 kg/m2.
• Chronic pain or chronic opioid therapy.
• Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Tea; Bupivacaine

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ashraf Habib, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: October 10, 2024
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)