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临床试验/NCT05133687
NCT05133687已完成3 期

The Hemodynamic Effects of Different Volumes of Bupivacaine 0.25% Caudal Blocks in Pediatrics Undergoing Lower Abdominal Surgeries as Measured by Electrical Cardiometry: A Randomized Controlled Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
The percentage of change from the baseline measurement of the cardiac index CI 10 minutes after successful caudal block.

研究概览

简要总结

This randomized, controlled study is designed to estimate the effects of different volumes of plain bupivacaine 0.25% caudal block on different hemodynamic parameters assessed by electrical cardiometry.

详细描述

Introduction:

Caudal block is one of the most used regional blocks in pediatrics because it is safe and provides efficient and adequate perioperative analgesia for most of the infra-umbilical and lower limb procedures.[1,2] It has been proposed that the cardiovascular effects of neuraxial blocks are less marked in children than in adults because of lower systemic vascular resistance (SVR) in pediatric population.[3] There is a wide range of doses used in caudal block depending on the desired dermatomal level which can range from 0.5ml/kg up to 1.25ml/kg. [1] However, studies assessing effects and safety of different volumes of caudal blocks on different hemodynamic variables are scarce and show conflicting results due to small sample sizes, absence of control groups, retrospective nature, different additives and different methods for measuring the hemodynamics.[4-8] Electrical Cardiometry (EC) estimates cardiac parameters by measuring changes in thoracic electrical bioimpedance during the cardiac cycle using skin electrodes. It has emerged as a new noninvasive tool for assessment of cardiac output with a good accuracy in adult and pediatric anesthesia.[9] The current study is designed to estimate the effects of different volumes of bupivacaine 0.25% caudal block on different hemodynamic parameters assessed by electrical cardiometry.

Hypothesis:

We hypothesized that different volumes of plain bupivacaine 0.25% caudal block could have direct effects on different hemodynamic parameters in pediatrics undergoing lower abdominal surgeries.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The concealed envelopes will be opened by an anesthesia resident (who will not be involved in patient management) and he will be responsible for preparing and giving the caudal block for the caudal groups as instructed in the envelope. the data will be collected by another anesthetist who is blinded to the group assignment.

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All pediatrics ASA I&II aged 1-8 years undergoing elective lower abdominal surgeries.

排除标准

  • ASA ≥ III. Parents refusal of caudal block. Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5). Patients with suspected or proved allergic to local anesthetics. Rash or signs of infection at the injection site. Patients requiring emergency or laparoscopic procedures.

研究组 & 干预措施

Group (0.8-G)

Experimental

This group will receive general anesthesia and caudal block with 0.8 ml/kg of bupivacaine 0.25%

干预措施: Bupivacaine Hydrochloride (Drug)

Group (1.2-G)

Experimental

This group will receive general anesthesia and caudal block with 1.2 ml/kg of bupivacaine 0.25%

干预措施: Bupivacaine Hydrochloride (Drug)

Group G

Active Comparator

This group will receive general anesthesia with local infiltration of the wound or transversus abdominis plan block (TAPB) at the end of the procedure.

干预措施: Bupivacaine Hydrochloride (Drug)

结局指标

主要结局

The percentage of change from the baseline measurement of the cardiac index CI 10 minutes after successful caudal block.

时间窗: 10 minutes after caudal block.

次要结局

  • mean ABP(1-2 hours)
  • Incidence of complications: block failure, bradycardia (HR < 80/min) , hypotension (blood pressure <20% of base line) and local anesthesia systemic toxicity (LAST)(1-2 hours)
  • heart rate(1-2 hours)
  • Electrical cardiometry cardiac index(30 minutes)

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

Khaled Abdelfattah Abdallah Sarhan

principal investigator,Lecturer of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (1)

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