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NCT Number: NCT06941259

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

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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Key information

Conditions

Regional Anesthesia Morbidity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectus sheath and ilioinguinal nerve block with physiological saline

Procedure

Rectus sheath and ilioinguinal nerve block without local anaesthesia

Other names: Group A (Sham)

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Procedure

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Other names: Group B (Block)

Primary outcomes

  1. Primary Outcome

    Time frame: 24 hours post-surgery

    Determination of the total amount of narcotic painkillers used during this period.

Secondary outcomes

  1. 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.

  2. Secondary Outcome

    Time frame: 24 hours post-surgery

    Incidence of narcotic-related side effects

  3. Secondary Outcome

    Time frame: through patient discharge postoperative, an average of 5 days postoperatively

    Length of hospital stay

  4. Secondary Outcome

    Time frame: 1,3,6,12 hours post-surgery

    Determination of the total amount of narcotic painkillers used.

  5. 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.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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