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

NCT ID: NCT06837909

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-02-01

Brief 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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transversus abdominis plane (TAP) block

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Wound infiltration

Intervention Type: PROCEDURE

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

Interventions

Transversus 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.

Intervention Type: PROCEDURE

Wound infiltration

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

karam azem

Attending Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Karam Azem, MD

Role: CONTACT

dr.azem.k@gmail.com

+972 50 470 5001

Facility Contacts

Binyamin Eisen, PhD

Role: primary

binyae@gmail.com

+972 52 311 5304

Other Identifiers

0131-25-RMC

Identifier Type: -

Identifier Source: org_study_id