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

NCT06837909 | Recruiting DMC

• 1 other identifier: 0131-25-RMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

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.

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

Secondary Outcomes (5)

• Pain scores

  Within 48 hours postoperatively

• Opioid Consumption

  Within 48 hours postoperatively

• Incidence of postoperative pulmonary complications

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

• Length of post-anesthesia care unit (PACU) stay

  Typically within 6 hours postoperatively

• Length of Hospital Stay

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

Study Arms (2)

TAP Block Group

EXPERIMENTAL

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

Wound Infiltration Group

ACTIVE COMPARATOR

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

Wound infiltration PROCEDURE

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

Wound Infiltration Group

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.

TAP Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Karam Azem, MD

CONTACT

+972 50 470 5001; dr.azem.k@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Operating room staff (anesthesiologists and surgeons) are unblinded due to the nature of the interventions. Patients, the physician measuring peak expiratory flow, PACU staff, and transplantation surgical ward nursing staff are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

IL (1)