Clinical trial NCT06941259: Effects of Combined Rectus Sheath and Ilioinguinal Nerve Block on Opioid Consumption in HALDN
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Regional Anesthesia Morbidity
Keywords: rectus sheath block
ilioinguinal nerve block
hand assisted donor nephrectomy
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 24 hours post-surgery
measure: Secondary Outcome
timeFrame: 24 hours post-surgery
measure: Secondary Outcome
timeFrame: through patient discharge postoperative, an average of 5 days postoperatively
measure: Secondary Outcome
timeFrame: 1,3,6,12 hours post-surgery
measure: Secondary Outcome
timeFrame: 1,3,6,12 hours post-surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
state: Zeytinburnu
Study officials:
affiliation: Koç University
name: Yasemin Sincer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.