A Comparative Study Between Combined Ketorolac Bupivacaine and Bupivacaine Alone for Transversus Abdominis Plane Block in Children Undergoing Lower Abdominal Surgeries: A Prospective Double- Blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1st analgesic requirement
研究概览
简要总结
Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)
详细描述
This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:
- History taking from the parents.
- Complete physical examination.
- Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation
Before starting, standard monitoring will be as follow:
- Non-invasive blood pressure (systolic and diastolic).
- Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.
Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.
排除标准
- •Parents' or legal guardians' refusal.
- •A history of developmental delay or mental retardation.
- •ASA III and IV.
- •A known allergy to ketorolac or bupivacaine.
- •Hemodynamic unstable patient
- •Urgent surgeries
研究组 & 干预措施
TAP block with bupivacaine and ketorolac
Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
干预措施: Bupivacain (Drug)
TAP block with bupivacaine and ketorolac
Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
干预措施: Ketorolac (Drug)
TAP block with bupivacaine
ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).
干预措施: Bupivacain (Drug)
结局指标
主要结局
1st analgesic requirement
时间窗: 24 hours
the time at which the 1st need for analgesia is given.
Number of patients who requested analgesia
时间窗: 24 hours
Number (percentage)of patients who requested analgesia
次要结局
- heart rate(24 hours)
- Total rescue analgesia(24 hours)
- Satisfaction of the parents regarding their children analgesia(24 hours)
- Number of children in each group who required analgesia in the first 24 h postoperatively(24 hours)
- blood pressure(24 hours)
研究者
Fouad Soliman
Lecturer of Anesthesia and ICU
Sohag University