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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rabin Medical Center, Beilinson Hospital
  Petah Tikva, Israel Recruiting

Study contacts

• Study coordinator: Karam Azem, MD
• Email: dr.azem.k@gmail.com
• Phone: +972 50 470 5001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.