Rectus Sheath Block for Analgesia After Gynecological Laparotomy

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Surgical Procedures
• Intervention / Treatment: Procedure: Rectus sheath block; Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride; Procedure: Thoracic Epidural Analgesia; Drug: Bupivacaine-Hydromorphone Cassette

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rectus Sheath Block Group (Prospective arm); 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; 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.; 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
Active Comparator: Thoracic Epidural Analgesia Group (retrospective arm); 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; Low thoracic Epidural Analgesia.; Drug: Bupivacaine-Hydromorphone Cassette; Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative opioid consumption 0- 72 hours after surgery	0-72 hours after time 0 (end of surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Number of patients developing ileus or constipation		0-72 hours after time 0 (end of surgery)
Number of patients with respiratory Depression		0-72 hours after time 0 (end of surgery)
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)	Visual analog scores 0-10 (0=no pain, 10=worst possible pain)	0-72 hours after time 0 (end of surgery)
Maximum pain scores reported	Visual analog scores 0-10 (0=no pain, 10=worst possible pain)	0-72 hours after time 0 (end of surgery)
Time to mobilization		0-72 hours after time 0 (end of surgery)
Time to urinary catheter removal		0-72 hours after time 0 (end of surgery)
Duration of post anesthesia care unit (PACU) stay		0-6 hours after time 0 (end of surgery)
Duration of hospital stay		0-10 days after surgery
Number of patients receiving intraoperative vasopressors		Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications related to rectus sheath block or epidural analgesia	Inadvertent dural puncture, postdural puncture headache, need to discontinue epidural due to hypotension, epidural hematoma.	0-72 hours after time 0 (end of surgery)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf Habib, M.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anilides; Amides; Aniline Compounds; Amines; Beverages; Plant Preparations; Biological Products; Complex Mixtures; Bupivacaine; Tea
• Other Study ID Numbers: Pro00115981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes