Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Time for first analgesic request
研究概览
简要总结
The transversus abdominis plane (TAP) block is a relatively simple technique that provides myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in the prevention and treatment of parietal postoperative pain.
Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided technique in different surgical procedures such as cesarean section, appendicectomy, laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients. Recently published clinical trials suggest that TAP block may represents an effective alternative to epidural anesthesia but further studies in larger population are necessary.
Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal laparotomy (2). Others found comparable results between continuous transversus abdominis plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing effects, technical simplicity, and long duration of action. Some disadvantages include the need for bilateral block for midline incisions and absence of effectiveness for visceral pain (4). TAP block has been associated with good pain relief and decreased intraoperative and postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of the TAP block has been demonstrated in prospective randomized trials compared with placebo, in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8, 9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in terms of reduction in visual analogue scale scores and morphine consumption. In this study the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block for postoperative pain control after lower abdominal surgeries in pediatrics.
详细描述
Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.
Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).
Anesthesia would be maintained with 2% sevoflurane and nitrous oxide.
An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower abdominal surgery
排除标准
- •Allergy to study medications
- •Contraindications to caudal block
- •Contraindications to transversus abdominis block
研究组 & 干预措施
Transversus abdominis plane block
Transversus Abdominis Plane block
干预措施: Transversus abdominis plane block (Other)
Transversus abdominis plane block
Transversus Abdominis Plane block
干预措施: Bupivacaine (Drug)
Caudal block
Caudal block
干预措施: Caudal block (Other)
Caudal block
Caudal block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time for first analgesic request
时间窗: 24 hours after surgery
By investigators until hospital discharge, then through telephone interview with parents after that
次要结局
- Parent satisfaction scores(24 hours after surgery)
- Total opioid consumption(24 hours after surgery)
- Sedation level(12 hours after surgery)
- Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS),(2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery)
研究者
Mohamed R El Tahan
Associate Professor
Mansoura University
