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临床试验/NCT04838314
NCT04838314终止不适用

Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve Analgesia and Reduce Opioid Consumption for Liver Transplantation in Recipient Paediatric Patient

Vinmec Healthcare System1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
peri operative Opioids consumption

研究概览

简要总结

Pediatric Liver transplantation surgery is associated with moderate to severe postoperative pain that is related to large abdominal incision cutting muscles and fascia and the anterior abdominal wall and drains. Peri-operative pain management after this surgery is centered on intravenous opioids, which cannot provide complete pain relief and are responsible for side effects such as vomiting or respiratory depression. Fifty-two per cent of pediatric patients reported moderate to severe pain on the day of surgery and 33% on day 1. 42% of patients reported vomiting. Increasing interest has focused on opioid sparing analgesic strategies to avoid some of the detrimental side effects of opioids. Recently, the focus has been on postoperative regional analgesia after major pediatric in major thoracic or abdominal surgeries. Thoracic epidural anesthesia or paravertebral blocks are efficacious but raise some concerns related to their potential complications especially in Liver transplantation with the risk of coagulation disorders.

Erector spinae plane block (ESPB) is an interfascial plane block whereby Local anesthestic (LA) is injected beneath the iliocostalis, longissimus, and spinalis muscles to achieve multi metameric analgesia for pediatric thoracic, cardiac, or abdominal surgery.

I Investigators' hypothesis is with efficient peri operative regional analgesia will reduce the opioids consumption, allow a very early extubation after such long surgeries and improve the quality of recovery by reducing the side effects of opioids as sedation. nausea vomiting delay of first intake.

详细描述

  1. Goals:

Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in paediatric patients for liver transplantation reduce the peri operative opioid consumption 2. Methodology:

  • Selection criteria:

  • Age > 1 to 15 years old

  • Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal)

  • Agree to participate in the trial ( Parents or guardians)

  • Exclusion criteria:

  • Refusal participation.

  • Allergy to LA

  • Intubated ventilated pre-operation

  • Severe coagulation disorder

  • Coma

  • Prediction of large volume liver implanted

  • After surgery performed

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
None

入排标准

年龄范围
12 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Recipient liver transplantation who accepted to participate ( parents or guardians)

排除标准

  • Refusal participation.
  • Allergy to LA
  • Intubated ventilated pre-operation
  • Severe coagulation disorder
  • Prediction of large volume liver implanted
  • After surgery performed Large volume implanted with a need of post operative controlled ventilation
  • After surgery performed Organ failure
  • After surgery performed Unstable patient

结局指标

主要结局

peri operative Opioids consumption

时间窗: up to day 7 after the end of surgery

Dose of opioids used

次要结局

  • Time to extubate(up to 6 hours after the end of the surgery)
  • Duration of stay in Intensive care Unit (ICU)(up to 72 hours after the end of the surgery)
  • first intake(up to 72hours after the end of the surgery)
  • Length of stay in hospital(up to 30 day after the end of the surgery)
  • first mobilisation(up to 72hours after the end of the surgery)

研究者

发起方
Vinmec Healthcare System
申办方类型
Other
责任方
Sponsor

研究点 (1)

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