Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-11-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Gynecologic Surgical Procedures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rectus sheath block

Intervention Type 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.

Liposomal bupivacaine

Intervention Type DRUG

133 mg liposomal bupivacaine per side for rectus sheath block

Bupivacaine Hydrochloride

Intervention Type DRUG

20 mL bupivacaine 0.25% per side for rectus sheath block

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.

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Analgesia

Intervention Type PROCEDURE

Low thoracic Epidural Analgesia.

Bupivacaine-Hydromorphone Cassette

Intervention Type DRUG

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

Interventions

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