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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain

• Registration Number: NCT06837909
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-05-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage Change in Forced Expiratory Volume in the First Second (FEV1)	Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)	Percentage change in FEV1 (measured in liters) between preoperative baseline and post-anesthesia care unit discharge.
Percentage Change in Forced Vital Capacity (FVC)	Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)	Percentage change in FVC (measured in liters) between preoperative baseline and post-anesthesia care unit discharge.
Percentage Change in Peak Expiratory Flow (PEF)	Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)	Percentage change in PEF (measured in liters per second) between preoperative baseline and post-anesthesia care unit discharge.

Secondary Outcome Measures

Name	Time	Method
Pain scores	Within 48 hours postoperatively	Pain intensity, measured using a 0-10 Numeric Rating Scale (NRS)
Opioid Consumption	Within 48 hours postoperatively	Opioid consumption, measured in morphine milligram equivalence (MME)
Incidence of postoperative pulmonary complications	Within 48 hours postoperatively	Based on the European perioperative clinical outcome (EPCO) criteria.
Length of post-anesthesia care unit (PACU) stay	Typically within 6 hours postoperatively	The total time (in hours) a patient remains in the PACU
Length of Hospital Stay	From the day of surgery until hospital discharge (typically within 3-5 days postoperatively)	The total length of hospital stay (in days) from surgery until hospital discharge

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petah Tikva, Israel