TAP block versus wound infiltration to preserve breathing after laparoscopic kidney donation

Transversus Abdominis Plane Block Versus Wound Infiltration for Pulmonary Function Preservation Following Laparoscopic Living Donor Nephrectomy (The TAPWIN Trial): A Double-Blind Randomized Controlled Trial

We will test whether a transversus abdominis plane (TAP) block or wound infiltration better preserves lung function in adults donating a kidney by laparoscopic surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rabin Medical Center (Academic / other)
• Locations: 1 site (Petah Tikva)
• Trial ID: NCT06837909 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized trial enrolling 80 adult living kidney donors undergoing laparoscopic nephrectomy who will be assigned to either an ultrasound-guided TAP block before surgery or wound infiltration with local anesthetic at the end of surgery. All participants receive standardized general anesthesia and multimodal analgesia, and outcome assessors are blinded to group assignment. The primary outcome is the percent change in peak expiratory flow (PEF) from before surgery to discharge from the recovery room, with secondary outcomes including pain scores, opioid consumption, breathing complications, and length of stay. The trial compares the two techniques' ability to reduce postoperative splinting and preserve effective coughing and deep breaths.

Who should consider this trial

Good fit: Adults over 18 scheduled for elective laparoscopic living donor nephrectomy with BMI 20–40 kg/m2 who can give informed consent and have no major cardiopulmonary disease are ideal candidates.

Not a fit: Patients with significant cardiac or pulmonary disease, preexisting chronic pain, allergies or contraindications to regional anesthesia or multimodal analgesic components, or those having open/hand-assisted procedures are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the preferred technique could help donors breathe better after surgery, reduce pain and opioid needs, and lower the risk of pulmonary complications.

How similar studies have performed: Previous studies show both TAP block and wound infiltration can reduce postoperative pain and opioid use, but few randomized trials have directly compared their effects on postoperative lung function.

Eligibility criteria

Inclusion Criteria:

* Patients who are scheduled to undergo elective LLDN.
* Age above 18 years.
* Body Mass Index (BMI) above 20 and below 40 kg m-2.
* Eligible to sign informed consent.

Exclusion Criteria:

* Open or hand-assisted surgery.
* Known cardiac or pulmonary disease.
* Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
* Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
* Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
* Preexisting severe pulmonary disease (i.e., an obstructive lung disease with a forced expiratory volume in the first second \[FEV1\] below 49%, restrictive lung disease with a forced vital capacity \[FVC\] below 49%, pulmonary hypertension).

Discontinuing criteria:

Participants will be excluded from the analysis if they:

* Experience intraoperative bleeding requiring transfusion of more than three units of blood products.
* Experience hemodynamic instability requiring postoperative vasopressor or inotropic support.
* Require conversion to open surgery.
* Require mechanical ventilation after being transferred from the OR to the PACU.

Where this trial is running

Petah Tikva

• Rabin Medical Center, Beilinson Hospital — Petah Tikva, Israel (Recruiting)

Study contacts

• Study coordinator: Karam Azem, MD

Conditions Postoperative Pain