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

NCT06941259 | Completed DMC

• 1 other identifier: 2024.394.IRB1.046
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Regional Anesthesia Morbidity

Keywords

rectus sheath block; ilioinguinal nerve block; hand assisted donor nephrectomy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

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

  24 hours post-surgery

Secondary Outcomes (5)

• Secondary Outcome

  24 hours post-surgery

• Secondary Outcome

  24 hours post-surgery

• Secondary Outcome

  through patient discharge postoperative, an average of 5 days postoperatively

• Secondary Outcome

  1,3,6,12 hours post-surgery

• Secondary Outcome

  1,3,6,12 hours post-surgery

Study Arms (2)

Group Sham

SHAM COMPARATOR

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

Group Block

ACTIVE COMPARATOR

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

Interventions

Rectus sheath and ilioinguinal nerve block with physiological saline PROCEDURE

Rectus sheath and ilioinguinal nerve block without local anaesthesia

Also known as: Group A (Sham)

Group Sham

Rectus sheath and ilioinguinal nerve block with local anaesthesia PROCEDURE

Rectus sheath and ilioinguinal nerve block with local anaesthesia

Also known as: Group B (Block)

Group Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

Related Publications (2)

• Ozkalayci O, Karakaya MA, Yenigun Y, Cetin S, Darcin K, Akyollu B, Arpali E, Kocak B, Gurkan Y. Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial. Minerva Anestesiol. 2024 Mar;90(3):154-161. doi: 10.23736/S0375-9393.23.17706-6. Epub 2024 Feb 2.

  PMID: 38305014 RESULT

• Gunaydin B, Ucar T, Arpali E, Akyollu B, Akinci S, Karatas C, Oztorun K, Kocak B. Hand-assisted laparoscopic donor nephrectomy: 1864 cases in 15 years of experience. Turk J Med Sci. 2022 Aug;52(4):1322-1328. doi: 10.55730/1300-0144.5438. Epub 2022 Aug 10.

  PMID: 36326419 RESULT

MeSH Terms

Interventions

salicylhydroxamic acid; Anesthesia, Local; Dental Occlusion

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Yasemin Sincer, MD

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: April 23, 2025
• Study Start: March 30, 2025
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)