Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Duke University

Status and phase: Completed; Phase 4

Conditions: Gynecologic Surgical Procedures

Treatments: Drug: Bupivacaine Hydrochloride; Procedure: Thoracic Epidural Analgesia; Procedure: Rectus sheath block; Drug: Bupivacaine-Hydromorphone Cassette; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06575699

Pro00115981

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Rectus Sheath Block Group (Prospective arm)

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

Procedure: Rectus sheath block

Drug: Bupivacaine Hydrochloride

Thoracic Epidural Analgesia Group (retrospective arm)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine-Hydromorphone Cassette

Procedure: Thoracic Epidural Analgesia