NCT07396753 The Effects of Transversalis Fascia Plane Block on Opioid Consumption in Patients Undergoing Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized Controlled Prospective Study
| NCT ID | NCT07396753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Koç University |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-07-25 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Yavuz Gurkan, Prof
STUDY DIRECTOR
Koc University Hospital
Frequently Asked Questions
Who can join the NCT07396753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07396753 currently recruiting?
Yes, NCT07396753 is actively recruiting participants. Contact the research team at sincer.yasemin@gmail.com for enrollment information.
Where is the NCT07396753 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07396753 clinical trial?
NCT07396753 is sponsored by Koç University. The principal investigator is Yavuz Gurkan, Prof at Koc University Hospital. The trial plans to enroll 50 participants.