Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
Location status: Recruiting
Location contact
Binyamin Eisen, PhD
CONTACT
Karam Azem, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06837909
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Petah Tikva, Israel
Location status: Recruiting
Binyamin Eisen, PhD
CONTACT
Karam Azem, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Discontinuing criteria:
Participants will be excluded from the analysis if they:
A regional anesthesia technique in which a local anesthetic is injected into the transversus abdominis plane under ultrasound guidance to provide postoperative analgesia.
A local anesthetic technique where bupivacaine with epinephrine is injected directly into the surgical wound sites to provide postoperative analgesia.
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.
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.
Time frame: Within 48 hours postoperatively
Opioid consumption, measured in morphine milligram equivalence (MME)
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.
Time frame: Typically within 6 hours postoperatively
The total time (in hours) a patient remains in the PACU
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
Contact information is provided by the study sponsor or research team.
Rabin Medical Center
Other
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
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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