Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07396753

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether the transversalis fascia plane block (TFPB), a regional anesthesia technique, can improve pain control after hand-assisted laparoscopic donor nephrectomy (HALDN), a minimally invasive surgery for living kidney donors. The study aims to see if adding TFPB reduces opioid pain medication use and improves pain relief during the first 24 hours after surgery. This prospective, randomized controlled trial involves adult living kidney donors aged 18 to 80 approved for HALDN. Participants will be randomly assigned to one of two groups. One group will receive standard general anesthesia alone, while the other will receive general anesthesia plus an ultrasound-guided TFPB using 30 mL of 0.25% bupivacaine injected into the lower abdominal wall. All patients will receive standard postoperative pain treatment including paracetamol and patient-controlled morphine. Pain scores and opioid-related side effects will be monitored for 24 hours after surgery. During the study, patients will be assessed for opioid consumption within 24 hours, pain scores using the Numeric Rating Scale every 6 hours, and opioid side effects like nausea or itching. Patient satisfaction with pain control will also be recorded. The trial includes close monitoring of medication use and adverse events to compare pain management effectiveness between groups. Participation involves surgery, anesthesia, postoperative care, and follow-up assessments during the first day after surgery.

CONDITIONS

Brief 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
  • Aged between 18 and 80 years
Not Eligible

You will not qualify if you...

  • Known allergy to any medications used in the study, including local anesthetics or opioids
  • Chronic opioid use or use of opioid receptor agonists
  • Inability to communicate effectively, such as due to cognitive impairment or language barriers
  • 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 of III or higher

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo hand-assisted laparoscopic donor nephrectomy under general anesthesia. Some participants receive an additional ultrasound-guided transversalis fascia plane block to reduce postoperative pain. After surgery, pain management is provided in the post-anesthesia care unit and surgical ward.

1 surgery day visit including post-anesthesia care unit monitoring

Post-operative Follow-up

Duration - 24 hours after surgery

Participants are monitored for postoperative pain, opioid consumption, and side effects during the first 24 hours after surgery. Pain scores are recorded every 6 hours, and rescue analgesics are provided if needed.

Visits or assessments every 6 hours for 24 hours

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

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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Published Research Related To This Trial

Systematic review and meta-analysis of the effect of nerve block under ultrasound in ilioinguinal/iliohypogastric in children.

Junming Chen, Daiqiang Song, Guifeng Zheng...

https://pubmed.ncbi.nlm.nih.gov/36345442

Effects of erector spinae plane block on opioid consumption in patients undergoing hand-assisted laparoscopic donor nephrectomy: a randomized controlled trial.

Özlem Özkalayci, Muhammet A Karakaya, Yılmaz Yenigün...

https://pubmed.ncbi.nlm.nih.gov/38305014