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

Koç University

Status: Enrolling

Conditions: Regional Anesthesia Morbidity

Treatments: Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesia; Procedure: Rectus sheath and ilioinguinal nerve block with physiological saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06941259

2024.394.IRB1.046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group Sham

Sham Comparator group

Description:

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.

Treatment:

Procedure: Rectus sheath and ilioinguinal nerve block with physiological saline

Group Block

Active Comparator group

Description:

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.

Treatment:

Procedure: Rectus sheath and ilioinguinal nerve block with local anaesthesia