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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage Change in Peak Expiratory Flow (PEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo elective LLDN.
- •Age above 18 years.
- •Body Mass Index (BMI) above 20 and below 40 kg m-
- •Eligible to sign informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Transversus abdominis plane (TAP) block (Procedure)
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.
干预措施: Wound infiltration (Procedure)
结局指标
主要结局
Percentage Change in Peak Expiratory Flow (PEF)
时间窗: 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.
次要结局
- 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))
研究者
karam azem
Attending Anesthesiologist
Rabin Medical Center