Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours postoperatively |
| Opioid Consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Discontinuing criteria:
Participants will be excluded from the analysis if they:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karam Azem, MD | Contact | +972 50 470 5001 | dr.azem.k@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Beilinson Hospital | Recruiting | Petah Tikva | Israel |
Not provided
Not provided
Not provided
Not provided
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.
| Wound infiltration | Procedure | A local anesthetic technique where bupivacaine with epinephrine is injected directly into the surgical wound sites to provide postoperative analgesia. |
|
Opioid consumption, measured in morphine milligram equivalence (MME)
| Within 48 hours postoperatively |
| Incidence of postoperative pulmonary complications | Based on the European perioperative clinical outcome (EPCO) criteria. | From the day of surgery until hospital discharge (typically within 3-5 days postoperatively) |
| Length of post-anesthesia care unit (PACU) stay | The total time (in hours) a patient remains in the PACU | Typically within 6 hours postoperatively |
| Length of Hospital Stay | The total length of hospital stay (in days) from surgery until hospital discharge | From the day of surgery until hospital discharge (typically within 3-5 days postoperatively) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided