Deep Rectus Sheath Block for Laparoscopic Cholecystectomy

NCT ID: NCT06976320

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholecystectomy, Laparoscopic Anesthesia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Intravenous morphine patient control analgesia

Intervention Type OTHER

24-hour morphine consumption will be recorded

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

Group Type ACTIVE_COMPARATOR

Intravenous patient control analgesia

Intervention Type OTHER

24-hour morphine consumption will be recorded

Deep rectus sheath block

Intervention Type OTHER

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

Interventions

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Intravenous morphine patient control analgesia

24-hour morphine consumption will be recorded

Intervention Type OTHER

Intravenous patient control analgesia

24-hour morphine consumption will be recorded

Intervention Type OTHER

Deep rectus sheath block

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taylan Sahin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Ali Sait Kavakli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Locations

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Istinye University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Taylan Sahin, M.D.

Role: CONTACT

+902129794000

Facility Contacts

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Taylan Sahin, M.D.

Role: primary

+902129794000

Other Identifiers

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Anestezi4

Identifier Type: -

Identifier Source: org_study_id

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