Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Phase 4

Recruiting

• Conditions: Gynecologic Surgical Procedures
• Interventions: Procedure: Rectus sheath block; Procedure: Thoracic Epidural Analgesia; Drug: Liposomal bupivacaine; Drug: Bupivacaine-Hydromorphone Cassette; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT06575699
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-28
• Study Start: 2024-10-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus Sheath Block Group (Prospective arm)	Bupivacaine Hydrochloride	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.
Rectus Sheath Block Group (Prospective arm)	Rectus sheath block	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.
Rectus Sheath Block Group (Prospective arm)	Liposomal bupivacaine	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.
Thoracic Epidural Analgesia Group (retrospective arm)	Thoracic Epidural Analgesia	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.
Thoracic Epidural Analgesia Group (retrospective arm)	Bupivacaine-Hydromorphone Cassette	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.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption 0- 72 hours after surgery	0-72 hours after time 0 (end of surgery)

Secondary Outcome Measures

Name	Time	Method
Number of patients with intraoperative hypotension	Intraoperative
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)	0-72 hours after time 0 (end of surgery)	Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
Maximum pain scores reported	0-72 hours after time 0 (end of surgery)	Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
Time to mobilization	0-72 hours after time 0 (end of surgery)
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 receiving rescue antiemetics	0-72 hours after time 0 (end of surgery)
Number of patients receiving intraoperative vasopressors	Intraoperative
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)
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 with postoperative hypotension	0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antipruritics	0-72 hours after time 0 (end of surgery)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States