Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Time to first rescue analgesia
研究概览
简要总结
combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children.
详细描述
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure.
General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane.
Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg.
After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II.
- •Unilateral hip surgery.
排除标准
- •Parents' refusal to participate in the study.
- •Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- •Localized infection at the site of needle insertion.
- •Known hypersensitivity or allergies to any of the used drugs.
- •Bilateral hip surgery in the same session.
研究组 & 干预措施
Group C
Patients will receive caudal analgesia
干预措施: Fentanyl (Drug)
Group C
Patients will receive caudal analgesia
干预措施: Morphine (Drug)
Group C
Patients will receive caudal analgesia
干预措施: Acetaminophen (Drug)
Group B
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
干预措施: Fentanyl (Drug)
Group B
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
干预措施: Morphine (Drug)
Group B
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
干预措施: Acetaminophen (Drug)
Group C
Patients will receive caudal analgesia
干预措施: Caudal epidural analgesia (Procedure)
Group B
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
干预措施: Ultrasound-guided Combined Pericapsular Nerve Group Block (Procedure)
Group B
patients will receive PENG block and Lateral Femoral Cutaneous Nerve block
干预措施: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block (Procedure)
结局指标
主要结局
Time to first rescue analgesia
时间窗: First 24 hours postoperative
Time (minutes) to first need of rescue analgesia postoperative.
次要结局
- Intraoperative hemodynamic parameters(intraoperative period)
- Total fentanyl consumption(intraoperative period)
- Total morphine consumption(First 24 hours postoperative)
- Postoperative pain assessment FLACC(First 24 hours postoperative)
研究者
maged gamal
Anesthesia lecturer
Kasr El Aini Hospital
