Deep Rectus Sheath Block for Laparoscopic Cholecystectomy

NCT06976320 | Recruiting

• 1 other identifier: Anestezi4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cholecystectomy, Laparoscopic; Anesthesia; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative numerical rating scale scores

  Postoperative 24 hours

• Rescue analgesic drug requirement

  Postoperative 24 hours

• Incidence of postoperative nausea and vomiting

  Postoperative 24 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR

The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia

Other: Intravenous morphine patient control analgesia

Deep rectus sheath block group

ACTIVE COMPARATOR

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: Intravenous patient control analgesia; Other: Deep rectus sheath block

Interventions

Intravenous morphine patient control analgesia OTHER

24-hour morphine consumption will be recorded

Control group

Intravenous patient control analgesia OTHER

24-hour morphine consumption will be recorded

Deep rectus sheath block group

Deep rectus sheath block OTHER

Deep rectus sheath block will be administered at the end of the surgery.

Deep rectus sheath block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Taylan Sahin, M.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

• Ali Sait Kavakli, M.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylan Sahin, M.D.

CONTACT

+902129794000; taylansah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: September 9, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

TU (1)