TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative pain at 2 hours
研究概览
简要总结
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children
详细描述
Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children.
The available local anesthesia techniques include wound infiltration or "wall" blocks such as the TAP (transversus abdominis plane) block.
The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time.
The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 3 and 16 years, candidates for laparoscopic appendectomy for suspected acute appendicitis.
- •ASA physical status Class I and II
- •Informed consent signed by parents / legal guardians
排除标准
- •severe obesity (BMI> 95th percentile for age and weight)
- •perforated appendicitis
- •paralytic ileum
- •non-stabilized neuropathies
- •allergy to local anesthetics or analgesics used in the study protocol.
- •patients on chronic opiate treatment
- •need for perioperative hospitalization in intensive care with sedation and / or mechanical ventilation
研究组 & 干预措施
TAP block
Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
干预措施: TAP Block (Procedure)
TAP block
Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
干预措施: General anesthesia (Procedure)
TAP block
Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side.
干预措施: Postperative analgesia (Drug)
LIA - local wound infiltration
Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
干预措施: LIA local infiltration (Procedure)
LIA - local wound infiltration
Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
干预措施: General anesthesia (Procedure)
LIA - local wound infiltration
Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg
干预措施: Postperative analgesia (Drug)
结局指标
主要结局
Postoperative pain at 2 hours
时间窗: 2 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 2 hours after the end of the surgery.
次要结局
- Total opioid consumption(from 2 to 24 postoperative hours)
- time to first opioid analgesic rescue(from 2 to 24 postoperative hours)
- Side effects(from 2 to 24 postoperative hours)
- Postoperative pain at 4-12-24 hours(from 4 to 24 postoperative hours)
研究者
Andrea Luigi Ambrosoli
Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte
Ospedale di Circolo - Fondazione Macchi