Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN

August 27, 2025 updated by: Koç University

Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy Patients: A Randomized Controlled Double-Blind Prospective Study

The goal of this double-blind randomized control clinical trial is to investigate the effectiveness of regional anaesthesia blocks (rectus sheath block and ilioinguinal nerve block) on pain management in patients undergoing hand assisted laparoscopic donor nephrectomy surgery. The main question it aims to answer is:

Does combined rectus sheath block and ilioinguinal nerve block lower the amount of postoperative opioid consumption? Does reduced postoperative opioid consumption reduce the incidence of potential opioid related side effects? Does the application of nerve block affect length of hospital stay?

Researchers will compare patients who had nerve blocks with regional anaesthesia to a placebo group to see if total postoperative opioid consumption.

Participants will be randomly divided in two. Regional anaesthesia with local anaesthesia or a placebo will be performed. Patients will be followed 24 hours postoperatively to measure total opioid consumption.

Possible side effects, complications and length of hospital stay will be noted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, it was planned to provide pain management after HALDN by applying a combined rectus sheath block and ilioinguinal nerve block. It is aimed to demonstrate the postoperative analgesic effectiveness of combined rectus sheath and ilioinguinal nerve block applied in addition to general anaesthesia in HALDN surgery. It was aimed to examine the amount of narcotic analgesic consumption in patients who received local anaesthetic for the first 24 hours after surgery. Regional anaesthesia applications with physiological saline, defined as 'Sham Block' in the literature, were preferred as the comparison group.

This method is a widely used comparison method and is used to obtain a double-blind study design.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey (Türkiye)
        • Koc University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The donors reviewed by the transplant committee and deemed suitable for nephrectomy.
  • Laparoscopic hand assisted donor nephrectomy operation is planned.

Exclusion Criteria:

  • Allergy to any of the drugs to be used in treatment
  • Patients using chronic narcotics or narcotic receptor agonists
  • Patients with psychiatric disorders
  • Patients with chronic organ failure
  • Patients without end organ damage
  • The patients who did not give consent
  • Foreign national patients
  • Patients with American Society of Anaesthesiologists (ASA) physical status classification score III and above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group Sham
After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing only physiological saline.
Procedure: Rectus sheath and ilioinguinal nerve block with physiological saline
Rectus sheath and ilioinguinal nerve block without local anaesthesia
Other Names:
  • Group A (Sham)
Active Comparator: Group Block
After the induction of general anaesthesia, the rectus sheath block and ilioinguinal nerve block will be performed to patients with a solution containing 0.25% bupivacaine.
Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesia
Rectus sheath and ilioinguinal nerve block with local anaesthesia
Other Names:
  • Group B (Block)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 24 hours post-surgery
Determination of the total amount of narcotic painkillers used during this period.
24 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 24 hours post-surgery
Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.
24 hours post-surgery
Secondary Outcome
Time Frame: 24 hours post-surgery
Incidence of narcotic-related side effects
24 hours post-surgery
Secondary Outcome
Time Frame: through patient discharge postoperative, an average of 5 days postoperatively
Length of hospital stay
through patient discharge postoperative, an average of 5 days postoperatively
Secondary Outcome
Time Frame: 1,3,6,12 hours post-surgery
Determination of the total amount of narcotic painkillers used.
1,3,6,12 hours post-surgery
Secondary Outcome
Time Frame: 1,3,6,12 hours post-surgery
Numeric rating scale scores for pain after surgery. Numeric rating scale scores for pain of 1 being minimum amount of pain and 10 being the worse pain.
1,3,6,12 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Principal Investigator: Yasemin Sincer, MD, Koc University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2025

Primary Completion (Actual)

July 28, 2025

Study Completion (Actual)

July 28, 2025

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.394.IRB1.046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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