Study of Transversalis Fascia Plane Block to Reduce Opioid Use After Hand-Assisted Laparoscopic Kidney Donation Surgery
Led by Koç University · Updated on 2026-02-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
Y
Yasemin Sincer, MD
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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
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
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
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
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...