Deep Rectus Sheath Block for Laparoscopic Cholecystectomy

Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

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 sheath 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Anesthesia; Cholecystectomy, Laparoscopic
• Intervention / Treatment: Other: Deep rectus sheath block; Other: Intravenous morphine patient control analgesia; Other: Intravenous patient control analgesia

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, numerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylan Sahin, M.D.; Phone Number: +902129794000; Email: taylansah@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istinye University Hospital
    • Contact: Taylan Sahin, M.D.; Phone Number: +902129794000; Email: taylansah@hotmail.com
    • Principal Investigator: Taylan Sahin, M.D.
    • Principal Investigator: Ali Sait Kavakli, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia	Other: Intravenous morphine patient control analgesia; 24-hour morphine consumption will be recorded
Active Comparator: Deep rectus sheath block group; The patients in deep rectus sheath block group will be received deep rectus sheath block and patient controlled analgesia with morphine for postoperative analgesia	Other: Deep rectus sheath block; Deep rectus sheath block will be administered at the end of the surgery.; Other: Intravenous patient control analgesia; 24-hour morphine consumption will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative numerical rating scale scores	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.	Postoperative 24 hours
Rescue analgesic drug requirement	The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.	Postoperative 24 hours
Incidence of postoperative nausea and vomiting	Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Istinye University
• Investigators: Principal Investigator: Ali Sait Kavakli, M.D., Istinye University; Principal Investigator: Taylan Sahin, M.D., Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 16, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Anestezi4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No