RecruitingNot ApplicableNCT06837909

Transversus Abdominis Plane Block Versus Wound Infiltration for Pulmonary Function Preservation Following Laparoscopic Living Donor Nephrectomy

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


Sponsor

Rabin Medical Center

Enrollment

80 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study compares two pain control techniques in patients undergoing laparoscopic kidney donation surgery: transversus abdominis plane (TAP) block versus wound infiltration with local anesthetic. Postoperative pain can impair breathing by causing patients to take shallow breaths to avoid discomfort. This study will evaluate which technique better preserves lung function, specifically peak expiratory flow (PEF), after surgery. Eighty patients will be randomly assigned to receive either a TAP block (injection of local anesthetic into the abdominal wall muscles before surgery) or wound infiltration (injection of local anesthetic at the incision sites at the end of surgery). Both patients and the staff measuring outcomes will be blinded to group assignment. The primary outcome is the percentage change in PEF from before surgery to discharge from the recovery room. Secondary outcomes include pain scores, opioid use, breathing complications, and length of hospital stay.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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.

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Interventions

PROCEDURETransversus abdominis plane (TAP) block

A regional anesthesia technique in which a local anesthetic is injected into the transversus abdominis plane under ultrasound guidance to provide postoperative analgesia.

PROCEDUREWound infiltration

A local anesthetic technique where bupivacaine with epinephrine is injected directly into the surgical wound sites to provide postoperative analgesia.


Locations(1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

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NCT06837909


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