Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Alexandre JOOSTEN, MD PhD (ucla)

Description

Summary

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.

Official Title

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)

Details

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.

Keywords

Opioid Analgesia, Quality of Recovery (QoR-15), Outcome Assessment, Opioid Free Anesthesia, opioids, quality of recovery, analgesia, moderate risk surgery, postoperative pain, Opioid Analgesics, Anesthetics, Opioid based Anesthesia

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Location

  • UCLA Ronald Reagan medical center
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06855641
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated