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临床试验/NCT04584151
NCT04584151终止不适用

Does Bilateral Continuous Peri Operative Erector Spinae Plane (ESP) Block Improve the Enhanced Recovery Program After Liver Transplantation in Recipient Patient

Vinmec Healthcare System2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
2
主要终点
Length of stay in hospital

研究概览

简要总结

Enhanced recovery after surgery (ERAS) programs were developed by Prof Henrik Kehlet in Denmark to reduce the hospitalization and improve the surgical outcomes. In these programs pain relief by regional analgesia techniques are highly recommended to reduced as much as possible the opioids used with their side effects. This program was created for colo-rectal surgeries and extended to other surgeries. In Liver transplants different programs has been described top reduce the use of peri-operative opioids but no with the ESP Animal and molecular studies in chronic pain showed the activation of glial cells, Monocytes and lymphocite K similar to the reaction during severe septis with immune reaction and toll like receptor activation. Regional anaesthesia analgesia is blocking this activation of Tool Like Receptors (TLR4) One of the discharge criteria after liver transplantation is the equilibrium of plasmatic cyclosporin Our hypothesis is with regional analgesia to avoid any immune disorder due to pain and reach earlier the discharge criteria than with standard analgesia Improve the quality of recovery and reduce the hospitalization stay after liver transplantation

详细描述

  1. Goals:

Compare quality of analgesia and quality of recovery between bilateral ESP bilateral catheters versus Opioid analgesia in adult included in an enhanced recovery program after liver transplantation Show that the addition of peri-operative regional analgesia improves the enhanced recovery program after open liver transplant in recipient patient . 2. Methodology:

•Selection criteria: Age > 18 years old Have a clinical indication for Liver transplantation ( list for surgeries listed in full proposal) Agree to participate in the trial

•Exclusion criteria: Use of chronic opioid Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergy to local anaesthetics) A diagnosis of a chronic pain condition Depression or other psychiatric diagnosis

• Study design: Prospective Randomized Controlled Trial.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age clinical indication for liver transplantation agree to participate and signed consent

排除标准

  • •Use of chronic opioid contra indication to perform ESP cathters Diagnosis of a chronic pain condition except liver disease Psychiatric or depression disorder allergy to local anesthetics

研究组 & 干预措施

standard of care

No Intervention

Peri operative analgesia by opioid

Continuous regiona analgesia

Experimental

Peri operative algesia by continuous bilateral ESP catheters

干预措施: regional analgesia (Procedure)

结局指标

主要结局

Length of stay in hospital

时间窗: up to 30 day

Time to reach the criteria of hospital discharge after liver transplantation

次要结局

  • Duration of stay in Intensive care Unit (ICU)(up to 72 hours)
  • Quality of recovery: score(up to 30 days)

研究者

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

研究点 (2)

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