Clinical trial NCT06837909: Transversus Abdominis Plane Block Versus Wound Infiltration for Pulmonary Function Preservation Following Laparoscopic Living Donor Nephrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares two different pain control techniques for patients undergoing laparoscopic living donor kidney surgery. Sixty donors will be randomly assigned to receive either a transversus abdominis plane (TAP) block or wound infiltration for pain management. The TAP block involves injecting pain medication between specific abdominal muscles, while wound infiltration involves injecting pain medication directly at the surgical sites. The study will assess how well each technique preserves breathing function and controls pain after surgery. Researchers will also track pain levels, pain medication use, breathing-related complications, and length of hospital stay. The goal of this research is to determine which technique more effectively supports recovery in kidney donors following surgery.

Detailed description: Living kidney donors undergo surgery purely for altruistic reasons, making optimal post-surgical recovery particularly important. Laparoscopic living donor nephrectomy (LLDN) has become the standard approach due to its advantages over open surgery, such as reduced pain, faster recovery, and shorter hospital stays. However, postoperative pain remains a challenge and can significantly impact pulmonary function, as donors may limit their chest movement to avoid discomfort.

This study investigates two regional analgesic techniques to address this issue: Transversus Abdominis Plane (TAP) Block and Wound Infiltration.

* TAP Block involves the ultrasound-guided injection of local anesthetic between muscle layers to target the nerves supplying the abdominal wall.
* Wound Infiltration involves direct injection of local anesthetic at the surgical sites.

Both techniques are routinely used in clinical practice, but their comparative effectiveness in preserving pulmonary function and managing pain in living kidney donors remains unclear.

This prospective, double-blind, randomized controlled trial (RCT) will rigorously compare these two techniques to determine their impact on postoperative pulmonary function, pain control, opioid consumption, and recovery outcomes. The primary outcome focuses on pulmonary function, as respiratory impairment directly affects postoperative recovery and donor well-being. Secondary outcomes will assess pain scores, opioid use, complications, and hospital stay duration, providing a comprehensive evaluation of both techniques in clinical practice.

The findings from this study could help establish evidence-based guidelines for postoperative pain management in living kidney donors, potentially improving the donation experience and supporting the continued growth of living kidney donation programs.

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.

Primary outcomes:
measure: Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)
measure: Percentage Change in Forced Vital Capacity (FVC)
timeFrame: Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)
measure: Percentage Change in Peak Expiratory Flow (PEF)
timeFrame: Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)
Secondary outcomes:
measure: Pain scores
timeFrame: Within 48 hours postoperatively
measure: Opioid Consumption
timeFrame: Within 48 hours postoperatively
measure: Incidence of postoperative pulmonary complications
timeFrame: Within 48 hours postoperatively
measure: Length of post-anesthesia care unit (PACU) stay
timeFrame: Typically within 6 hours postoperatively
measure: Length of Hospital Stay
timeFrame: From the day of surgery until hospital discharge (typically within 3-5 days postoperatively)
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
References: