CClinicalTrials.gg
RecruitingNCT06837909TAPWINUpdated Jan 7, 2026

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

An interventional study of Transversus abdominis plane (TAP) block and Wound infiltration in Postoperative Pain, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Postoperative Pain

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    TAP Block Group

    After anesthesia induction and before surgical incision, the anesthesiologist will perform an ultrasound-guided (Venue GO, GE Healthcare, USA) single-shot TAP block in the triangle of Petit with 20 mL 0.25% bupivacaine and 2.5 µg mL-1 of epinephrine on each side.

    Procedure: Transversus abdominis plane (TAP) block

  • Active comparator
    Wound Infiltration Group

    Following surgery conclusion and before awakening from anesthesia, the surgeons will inject 40 mL of 0.25% bupivacaine and 2.5 µg mL-1 of epinephrine at the wound sites.

    Procedure: Wound infiltration

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.

05

What researchers measure

Primary outcomes

  1. Percentage Change in Peak Expiratory Flow (PEF)

    Percentage change in PEF (measured in liters per second) between preoperative baseline and post-anesthesia care unit discharge.

    Time frame: Baseline (Preoperative) and PACU Discharge (Within 2-3 hours post-surgery)

Secondary outcomes

  1. Pain scores

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

    Time frame: Within 48 hours postoperatively

  2. Opioid Consumption

    Opioid consumption, measured in morphine milligram equivalence (MME)

    Time frame: Within 48 hours postoperatively

  3. Incidence of postoperative pulmonary complications

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

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

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

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

    Time frame: Typically within 6 hours postoperatively

  5. Length of Hospital Stay

    The total length of hospital stay (in days) from surgery until hospital discharge

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

06

Study locations

1 of 1 sites recruiting
  • Rabin Medical Center, Beilinson Hospital
    Petah Tikva, Israel
    • Binyamin Eisen, PhD · Contact · binyae@gmail.com · +972 52 311 5304
    • Karam Azem, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06837909
Lead sponsor
Rabin Medical Center
Responsible party
karam azem (Attending Anesthesiologist, Rabin Medical Center) — Principal investigator
First posted
Feb 20, 2025
Start date
Jan 1, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Jan 7, 2026

Study contacts

Karam Azem, MD
Contact
dr.azem.k@gmail.com
+972 50 470 5001

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion