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临床试验/NCT06417268
NCT06417268已完成2 期

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.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients will receive caudal analgesia

干预措施: Fentanyl (Drug)

Group C

Active Comparator

Patients will receive caudal analgesia

干预措施: Morphine (Drug)

Group C

Active Comparator

Patients will receive caudal analgesia

干预措施: Acetaminophen (Drug)

Group B

Active Comparator

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

干预措施: Fentanyl (Drug)

Group B

Active Comparator

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

干预措施: Morphine (Drug)

Group B

Active Comparator

patients will receive PENG block and Lateral Femoral Cutaneous Nerve block

干预措施: Acetaminophen (Drug)

Group C

Active Comparator

Patients will receive caudal analgesia

干预措施: Caudal epidural analgesia (Procedure)

Group B

Active Comparator

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

Active Comparator

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

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

maged gamal

Anesthesia lecturer

Kasr El Aini Hospital

研究点 (2)

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