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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2025-07-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Regional Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with physiological saline.

Group B: After patients anesthetized under general anaesthesia, a combined rectus sheath block and ilioinguinal nerve block will be applied with 0.25% bupivacaine.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

The patient will be blind whether they receive local anaesthesia or physiological saline as the nerve block ingredient.

The care providers will be blind to the solution when they are performing the regional anaesthesia.

The care providers will be blind when they are monitoring the patient after surgery.

Study Groups

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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.

Group Type SHAM_COMPARATOR

Rectus sheath and ilioinguinal nerve block with physiological saline

Intervention Type PROCEDURE

Rectus sheath and ilioinguinal nerve block without local anaesthesia

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.

Group Type ACTIVE_COMPARATOR

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Intervention Type PROCEDURE

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Interventions

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Rectus sheath and ilioinguinal nerve block with physiological saline

Rectus sheath and ilioinguinal nerve block without local anaesthesia

Intervention Type PROCEDURE

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Intervention Type PROCEDURE

Other Intervention Names

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Group A (Sham) Group B (Block)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes