The Effects of Transversalis Fascia Plane Block on Opioid Consumption in Patients Undergoing Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized Controlled Prospective Study

NCT07396753 | Recruiting

• 1 other identifier: 2025.030.IRB1.006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether a regional anesthesia technique called the transversalis fascia plane block (TFPB) can improve pain control after hand-assisted laparoscopic donor nephrectomy (HALDN), a minimally invasive surgery performed in living kidney donors. Although HALDN is less invasive than open surgery, patients often experience significant pain after the operation, mainly due to the surgical incisions in the lower abdomen and trocar entry sites. Poorly controlled pain can delay recovery and increase the need for opioid pain medications, which may cause side effects such as nausea, vomiting, itching, and sedation. The transversalis fascia plane block is an ultrasound-guided regional anesthesia technique in which a local anesthetic is injected into a specific tissue plane in the lower abdominal wall. This injection temporarily blocks pain signals from nerves supplying the lower abdomen and groin area. The technique has been shown to reduce pain and opioid use after various lower abdominal surgeries and is considered minimally invasive and safe when performed under ultrasound guidance. In this study, patients undergoing HALDN will be randomly assigned to one of two groups. One group will receive standard general anesthesia only, while the other group will receive general anesthesia plus a transversalis fascia plane block using a local anesthetic (bupivacaine). All patients will receive the same standard pain treatment after surgery, including paracetamol and patient-controlled morphine. The main goal of the study is to compare the amount of opioid pain medication used during the first 24 hours after surgery between the two groups. Secondary outcomes include pain scores measured using the Numeric Rating Scale (NRS), the frequency of opioid-related side effects, and patient satisfaction with pain control. The results of this study may help determine whether adding the transversalis fascia plane block to standard anesthesia can provide better pain relief, reduce opioid consumption, and improve comfort and recovery in living kidney donors.

Conditions

Postoperative Pain; Analgesics, Opioid; Pain Management; Anesthesia Regional; Living Donors; Nephrectomy,Kidney Donation

Keywords

Hand-assisted laparoscopic donor nephrectomy; Transversalis fascia plane block; Regional anesthesia; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption during the first 24 hours postoperatively

  Total cumulative opioid consumption (morphine-equivalent dose) within the first 24 hours following hand-assisted laparoscopic donor nephrectomy.

  24 hours after surgery

Secondary Outcomes (3)

• Postoperative pain scores using the Numeric Rating Scale (NRS)

  24 hours postoperatively

• Incidence of opioid-related adverse effects

  24 hours postoperatively

• Rescue analgesic use

  Time Frame: 24 hours postoperatively

Study Arms (2)

Group A

NO INTERVENTION

General anesthesia without regional block

Group B

ACTIVE COMPARATOR

General anesthesia + Ultrasound guided Transversalis Fascia Plane Block (with local anesthetic)

Procedure: Ultrasound-guided transversalis fascia plane block

Interventions

Ultrasound-guided transversalis fascia plane block PROCEDURE

Ultrasound-guided transversalis fascia plane block performed after induction of general anesthesia using a single-shot injection of 30 mL 0.25% bupivacaine between the posterior surface of the transversus abdominis muscle and the transversalis fascia, targeting T12-L1 thoracolumbar nerve branches (iliohypogastric and ilioinguinal nerves) for postoperative analgesia following hand-assisted laparoscopic donor nephrectomy.

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Approved by the transplant committee for living kidney donation
• Scheduled for hand-assisted laparoscopic donor nephrectomy (HALDN)
• Able to understand study procedures and provide written informed consent

You may not qualify if:

• Known allergy to any medications used in the study (e.g., local anesthetics, opioids)
• Chronic opioid use or use of opioid receptor agonists
• Inability to communicate effectively (e.g., cognitive impairment, language barrier)
• Chronic organ failure or major organ dysfunction
• Refusal or inability to provide informed consent
• Foreign nationality (if follow-up or consent is restricted)
• American Society of Anesthesiologists (ASA) physical status ≥ III

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Bainton A. Ilioinguinal/iliohypogastric nerve block. Anaesthesia. 1982 Jun;37(6):696-7. doi: 10.1111/j.1365-2044.1982.tb01289.x. No abstract available.

  PMID: 7091630 BACKGROUND

• Chen J, Song D, Zheng G, Luo Y. Systematic review and meta-analysis of the effect of nerve block under ultrasound in ilioinguinal/iliohypogastric in children. Transl Pediatr. 2022 Oct;11(10):1604-1614. doi: 10.21037/tp-22-308.

  PMID: 36345442 BACKGROUND

• Hamid HKS, Ahmed AY, Alhamo MA, Davis GN. Efficacy and Safety Profile of Rectus Sheath Block in Adult Laparoscopic Surgery: A Meta-analysis. J Surg Res. 2021 May;261:10-17. doi: 10.1016/j.jss.2020.12.003. Epub 2020 Dec 30.

  PMID: 33387729 BACKGROUND

• Fleishman A, Khwaja K, Schold JD, Comer CD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Pavlakis M, Mandelbrot DA, Rodrigue JR; KDOC Study Group. Pain expectancy, prevalence, severity, and patterns following donor nephrectomy: Findings from the KDOC Study. Am J Transplant. 2020 Sep;20(9):2522-2529. doi: 10.1111/ajt.15861. Epub 2020 Apr 12.

  PMID: 32185880 BACKGROUND

• Zorgdrager M, van Londen M, Westenberg LB, Nieuwenhuijs-Moeke GJ, Lange JFM, de Borst MH, Bakker SJL, Leuvenink HGD, Pol RA. Chronic pain after hand-assisted laparoscopic donor nephrectomy. Br J Surg. 2019 May;106(6):711-719. doi: 10.1002/bjs.11127. Epub 2019 Mar 27.

  PMID: 30919435 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Yavuz Gurkan, Prof

  Koç University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yasemin Sincer, MD

CONTACT

+90 531 2040834; sincer.yasemin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants are randomized into two separate groups Each participant receives only one intervention Group A: General anesthesia only Group B: General anesthesia + TFPB Outcomes are compared between groups, not within the same patient.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: July 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 3, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: March 2026-March 2031
• Access Criteria: Access to the de-identified individual participant data (IPD) and supporting documentation (study protocol, statistical analysis plan, and data dictionary) will be granted to qualified researchers upon reasonable request. Researchers must submit a proposal outlining the objectives of their analysis and obtain approval from the study's principal investigator. Shared data will include de-identified demographic information, perioperative opioid consumption, postoperative NRS pain scores, rescue analgesic use, incidence of opioid-related adverse events, and patient satisfaction scores. Data will be shared in a secure, password-protected format via institutional data-sharing platforms or secure file transfer. All recipients must agree to use the data solely for research purposes and to maintain participant confidentiality.

Locations

TU (1)