NCT06575699

Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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
DRUG	Bupivacaine-Hydromorphone Cassette	Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2024-08-28
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study