Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07396753

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

Led by Koç University · Updated on 2026-02-09

50

Participants Needed

1

Research Sites

31 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Known allergy to any medications used in the study such as local anesthetics or opioids
  • Chronic opioid use or use of opioid receptor agonists
  • Inability to communicate effectively due to cognitive impairment or 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 classification grade 3 or higher

AI-Screening

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Trial Site Locations

Total: 1 location

1

Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye), 34010

Actively Recruiting

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Research Team

Y

Yasemin Sincer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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