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临床试验/NCT04921007
NCT04921007已完成不适用

Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery

Sameh Fathy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月13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
已完成
发起方
Sameh Fathy
入组人数
60
试验地点
1
主要终点
Duration for the first analgesic request

研究概览

简要总结

This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.

详细描述

Regional anesthesia in children has become increasingly popular over the past few decades. A variety of peripheral and central nerve blocks have been developed to ensure that perioperative pain can be effectively controlled. So, it possible to reduce the dose concentrations of systemic drugs and improved hemodynamic stability in high-risk patients. Erector spinae plane (ESP) block with various approaches been used in many surgeries and obtained great popularity despite of its novelty. After first description; lower thoracic, lumbar and sacral approaches were defined for postoperative analgesia. There are a few cases in which sacral ESP block was administered and reported.

The aim of this study is to compare postoperative analgesic effect of ultrasound guided sacral ESP block and caudal block. It is hypothesized that sacral ESP block will be comparable to caudal block as a promising effective alternative for analgesia in patients who will undergo pediatric anorectal surgery with fewer side effects.

This prospective, randomized, comparative clinical study will include 60 children who will be scheduled for elective anorectal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to two equal groups (ESP and caudal) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for pediatric anorectal surgery

排除标准

  • Parental refusal of consent.
  • Children with developmental delays, mental or neurological disorders.
  • Bleeding or coagulation diathesis.
  • History of known sensitivity to the used anesthetics.
  • Infection or redness at the injection site.

研究组 & 干预措施

Group (A) Sacral ESP block

Active Comparator

Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

干预措施: Sacral ESP block (Procedure)

Group (A) Sacral ESP block

Active Comparator

Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

干预措施: Bupivacaine Hydrochloride (Drug)

Group (B) Caudal block

Active Comparator

Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

干预措施: Caudal block (Procedure)

Group (B) Caudal block

Active Comparator

Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

干预措施: Bupivacaine Hydrochloride (Drug)

结局指标

主要结局

Duration for the first analgesic request

时间窗: Up to 24 hours after the procedure

The time of the first analgesic request for paracetamol in minutes will be recorded.

次要结局

  • Changes in heart rate(Up to end of the surgery)
  • Changes in mean arterial blood pressure(Up to end of the surgery)
  • Value of parent satisfaction from the procedure(Up to 24 hours after the procedure)
  • Total analgesic requirements of paracetamol(Up to 24 hours after the procedure)
  • Improvement in pain scores(Up to 24 hours after the procedure)
  • Changes in postoperative emergence agitation scale(Up to 30 minutes after the procedure)

研究者

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

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