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临床试验/NCT05543109
NCT05543109Enrolling By Invitation不适用

Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block for Pain Management in Pediatric Patients With Developmental Dysplasia Sia of the Hip Joint, Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年9月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
85
试验地点
1
主要终点
Postoperative analgesic requirements

研究概览

简要总结

The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip

详细描述

All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.

Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.

The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.

Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing undergo acetabuloplasty
  • Anesthesiologists (ASA) physical status of I to II

排除标准

  • Known allergy to local anesthetic
  • Infection at the block site.

研究组 & 干预措施

Psoas compartment block

Active Comparator

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Fentanyl (Drug)

Psoas compartment block

Active Comparator

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Propofol (Drug)

Psoas compartment block

Active Comparator

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Rocuronium (Drug)

Psoas compartment block

Active Comparator

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Sevoflurane (Drug)

Psoas compartment block

Active Comparator

After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Ropivacaine (Drug)

Suprainguinal fascia iliaca compartment block

Active Comparator

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Fentanyl (Drug)

Suprainguinal fascia iliaca compartment block

Active Comparator

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Propofol (Drug)

Suprainguinal fascia iliaca compartment block

Active Comparator

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Rocuronium (Drug)

Suprainguinal fascia iliaca compartment block

Active Comparator

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Sevoflurane (Drug)

Suprainguinal fascia iliaca compartment block

Active Comparator

After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Postoperative analgesic requirements

时间窗: 8 hours

Postoperative Ketoprofen and morphine consumption

Intraoperative anesthetic requirement

时间窗: 1 hour

Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohamed Mogahed

Associate professor

Tanta University

研究点 (1)

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