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

ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRabin Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transversus abdominis plane (TAP) block

    Procedure/Surgery

    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/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TAP Block GroupExperimental treatment 1 intervention
Group B: Wound Infiltration GroupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rabin Medical Center

Lead sponsor

Source ClinicalTrials.gov
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