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临床试验/NCT06855641
NCT06855641已完成不适用

Patient Preference for Intraoperative Opioid Use and Early Recovery Following Non-Cardiac Surgery: Protocol for a Randomized Factorial Design Trial of Opioid-Free vs Opioid-Based Anesthesia (PERFECT TRIAL)

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Quality of recovery (QoR15)

研究概览

简要总结

Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. There have been no studies that have evaluated patient preference regarding opioid use and its potential impact on the quality of recovery.

The aim of this study is to compare the effect of patient preference on intraoperative opioid use on early postoperative quality of recovery following moderate risk laparoscopic/robotic abdominal surgery.

详细描述

Although opioid analgesic drugs are commonly used to relieve pain associated with surgery, they are not consequence free. Respiratory depression, postoperative nausea and vomiting (PONV), impaired gastrointestinal function, urinary retention are frequent concerns associated with their use. Moreover, the United States and many western countries are currently experiencing a significant health problem with opioid addiction and deaths due to overdose. Some opioid addiction pathways can trace their origin back to when a patient was first admitted to a hospital and received opioids in the setting of acute pain or surgery. As a result of this, there is likely a potential iatrogenic component to the current opioid abuse epidemic. Questioning the role of opioids is part of enhanced recovery after surgery programs, and good practice to reduce the risk of developing addiction and other side effects. Substituting the administration of opioids with a combination of alternative analgesics, known as opioid-free anesthesia (OFA), is gaining in popularity today and is typically administered as part of a larger multimodal strategy. However, OFA adoption is not as common today as one could expect from the potential benefits of limiting opioid use and patient involvement in the decision may impact its adoption. Relevant shared decision-making process with patients concerning the use or limited use of opioids could improve patient autonomy and empowerment. There have been no studies that have evaluated patient preference regarding opioid use and its potential impact on the quality of recovery.

The aim of this study is to compare the effect of patient preference on intraoperative opioid use on early postoperative quality of recovery following moderate risk laparoscopic/robotic abdominal surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

quality of recovery will be done by research coordinators and research students ( undergraduate students) not involved in patient care.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age >18 years.
  • •Undergoing elective intermediate risk surgery under general anesthesia (robotic or laparoscopic assisted urological, gynecological or abdominal surgery).
  • •American Society Anesthesiologists physical status classification system grades of I-IV.
  • •English speaking.
  • •Informed consent signed.

排除标准

  • •Diagnosis of chronic pain
  • •Preoperative prescribed opioids
  • •Pregnancy or lactation.
  • •History of mental disorders.
  • •Contraindications to study drug (lidocaine, magnesium, dexmedetomidine, ketamine)
  • •Patient is participating in another interventional trial
  • •Patient is under judicial protection or is an adult under guardianship.

研究组 & 干预措施

Patient choose his analgesia type

Experimental

The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)

干预措施: Opioid based Anesthesia (Procedure)

Patient choose his analgesia type

Experimental

The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)

干预措施: opioid free anesthesia (Procedure)

Patient does not choose his analgesia strategy

Active Comparator

If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA

干预措施: Opioid based Anesthesia (Procedure)

Patient does not choose his analgesia strategy

Active Comparator

If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA

干预措施: opioid free anesthesia (Procedure)

结局指标

主要结局

Quality of recovery (QoR15)

时间窗: Postoperative day 1

The primary outcome will be the comparison of early postoperative quality of recovery (QoR) on postoperative day 1 (POD#1) using the validated QoR-15 score (as a whole, and each item separately) between patients who choose vs don't choose their anesthesia strategies. The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery

次要结局

  • Quality of Recovery at postoperative day 2(Postoperative day 2)
  • PONV incidence(Postoperative day 2)
  • Anesthesia satisfaction(Postoperative day 1)
  • Postoperative opioid consumption(Postoperative 30)
  • Intraoperative bradycardia(during surgery)
  • Postoperative hypoxemia incidence(Postoperative day 2)
  • Health quality of life(Postoperative day 30)
  • Early quality of recovery on POD#1(Postoperative day 1)

研究者

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

Alexandre P. Joosten

Associate Professor

University of California, Los Angeles

研究点 (2)

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