Rectus Sheath Block for Analgesia After Gynecological Laparotomy

Duke University90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Gynecologic Surgical Procedures

Interventions

Rectus sheath blockPROCEDURE

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.

Thoracic Epidural AnalgesiaPROCEDURE

Low thoracic Epidural Analgesia.

Liposomal bupivacaineDRUG

133 mg liposomal bupivacaine per side for rectus sheath block

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Postoperative opioid consumption 0- 72 hours after surgery

Time frame: 0-72 hours after time 0 (end of surgery)

Secondary Outcomes

Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours

Time frame: 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)

Number of patients with intraoperative hypotension

Time frame: Intraoperative

Number of patients with postoperative hypotension

Time frame: 0-72 hours after time 0 (end of surgery)

Number of patients receiving rescue antiemetics

Time frame: 0-72 hours after time 0 (end of surgery)

Number of patients receiving rescue antipruritics

Time frame: 0-72 hours after time 0 (end of surgery)

Number of patients developing ileus or constipation

Time frame: 0-72 hours after time 0 (end of surgery)

Number of patients with respiratory Depression

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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