Transversalis fascia plane block to reduce opioid use after hand-assisted laparoscopic kidney donation
The Effects of Transversalis Fascia Plane Block on Opioid Consumption in Patients Undergoing Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized Controlled Prospective Study
This will try an ultrasound-guided transversalis fascia plane block to see if living kidney donors have less pain and need fewer opioid pain medicines after hand-assisted laparoscopic donor nephrectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Koç University Academic / other |
| Locations | 1 site (Istanbul, Zeytinburnu) |
| Trial ID | NCT07396753 on ClinicalTrials.gov |
What this trial studies
In this single-center, prospective randomized controlled trial at Koç University Hospital, adults approved for living kidney donation and scheduled for hand-assisted laparoscopic donor nephrectomy will be randomized to receive an ultrasound-guided transversalis fascia plane block with local anesthetic or standard care. The primary outcome is total opioid consumption in the first 24 hours after surgery, with secondary outcomes including numeric rating scale pain scores and opioid-related side effects. The block is performed preoperatively under ultrasound guidance to inject local anesthetic into the transversalis fascia plane of the lower abdominal wall. Key exclusions include chronic opioid use, allergy to local anesthetics, major organ dysfunction, ASA physical status III or greater, and inability to provide informed consent.
Who should consider this trial
Good fit: Adults approved for living kidney donation who are scheduled for hand-assisted laparoscopic donor nephrectomy, can give informed consent, and do not have chronic opioid use or contraindications to local anesthetics are ideal candidates.
Not a fit: Patients with chronic opioid use, allergy to the study medications, major organ dysfunction, ASA III or higher, or those unable to consent are unlikely to receive benefit from this intervention in the trial.
Why it matters
Potential benefit: If successful, the block could lower postoperative pain and opioid use, speeding recovery and reducing opioid-related side effects for living kidney donors.
How similar studies have performed: Regional abdominal nerve blocks have reduced pain and opioid use in other lower abdominal surgeries and some reports support TFPB for similar procedures, but high-quality evidence specifically for hand-assisted laparoscopic donor nephrectomy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Istanbul, Zeytinburnu
- Koç University Hospital — Istanbul, Zeytinburnu, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Yasemin Sincer, MD
- Email: sincer.yasemin@gmail.com
- Phone: +90 531 2040834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.