Deep Rectus Sheath Block for Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Cholecystectomy, Laparoscopic; Anesthesia; Postoperative Pain

• Registration Number: NCT06976320
• Lead Sponsor: Istinye University

Brief Summary

Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus shaeth block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numaerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-05-28
• Primary Completion: 2025-09-08
• Study Completion: 2025-10-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 and 80 years
• Patients with American Society of Anesthesiology (ASA) physical status I-II
• Patients scheduled for a laparoscopic cholecystectomy

Exclusion Criteria

• Allergy to local anesthetics
• Coagulopathy
• Skin infection at the deep rectus sheath block area
• Advanced hepatic or renal failure
• Chronic pain syndromes
• Alcohol or drug abuse
• Severe pulmonary and/or cardiovascular disease
• Psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Postoperative 24 hours	The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

Name	Time	Method
Postoperative numerical rating scale scores	Postoperative 24 hours	Postoperative pain will be assessed using a numerical rating scale (NRS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Rescue analgesic drug requirement	Postoperative 24 hours	The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Incidence of postoperative nausea and vomiting	Postoperative 24 hours	Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Trial Locations

Locations (1)

Istinye University Hospital; 🇹🇷 Istanbul, Turkey