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NCT Number: NCT06837909

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

Location status: Recruiting

Location contact

Binyamin Eisen, PhD

CONTACT

[email protected]

+972 52 311 5304

Karam Azem, MD

PRINCIPAL_INVESTIGATOR

About this study

Laparoscopic living donor nephrectomy (LLDN) is the gold-standard approach for kidney donation, offering reduced pain, shorter hospital stays, and faster recovery compared to open surgery. However, postoperative pain remains a concern, particularly because acute pain leads to protective "splinting" breathing patterns - shallow, rapid breaths that limit abdominal wall movement. This restricted breathing reduces thoracic expansion, inhibits deep inspiration, and impairs effective coughing, increasing the risk of pulmonary complications.

Among regional analgesic techniques, TAP block and wound infiltration have emerged as promising options for LLDN due to their simplicity and effectiveness. TAP block involves ultrasound-guided injection of local anesthetic between the internal oblique and transversus abdominis muscles, providing analgesia to the anterolateral abdominal wall. Wound infiltration directly targets the surgical incision sites. While both techniques reduce postoperative pain and opioid consumption, their comparative effectiveness in preserving pulmonary function remains unclear.

This double-blind randomized controlled trial will compare the effects of TAP block versus wound infiltration on peak expiratory flow (PEF) preservation following LLDN. All patients will receive standardized general anesthesia and multimodal analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transversus abdominis plane (TAP) block

Procedure

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

Wound Infiltration

Procedure

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

Primary outcomes

  1. Percentage Change in Peak Expiratory Flow (PEF)

    Time frame: 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 outcomes

  1. Pain scores

    Time frame: Within 48 hours postoperatively

    Pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse outcome.

  2. Opioid Consumption

    Time frame: Within 48 hours postoperatively

    Opioid consumption, measured in morphine milligram equivalence (MME)

  3. Incidence of postoperative pulmonary complications

    Time frame: From the day of surgery until hospital discharge (typically within 3-5 days postoperatively)

    Based on the European perioperative clinical outcome (EPCO) criteria.

  4. Length of post-anesthesia care unit (PACU) stay

    Time frame: Typically within 6 hours postoperatively

    The total time (in hours) a patient remains in the PACU

  5. Length of Hospital Stay

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Karam Azem, MD

CONTACT

[email protected]

+972 50 470 5001

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study 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

Acronym: TAPWIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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