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Completed

NCT Number: NCT06855641

Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Opioid based Anesthesia

Procedure

in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery

opioid free anesthesia

Procedure

In this group, patients will not receive any opioids intraoperatively

Primary outcomes

  1. Quality of recovery (QoR15)

    Time frame: 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

Secondary outcomes

  1. Quality of Recovery at postoperative day 2

    Time frame: Postoperative day 2

    QoR15 at postoperative day 2 (same as the primary outcome but assessed at POD#2). The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery

  2. PONV incidence

    Time frame: Postoperative day 2

    Incidence of postoperative nausea and vomiting defined as the use in percentage of any antiemetic drug in the post-anesthesia care unit (PACU) and from PACU discharge to home discharge (usually between postoperative day 1 and 2)

  3. Anesthesia satisfaction

    Time frame: Postoperative day 1

    Anesthesia satisfaction assessment with the Bauer questionnaire. Overall satisfaction and satisfaction by category prevalence (%). Self assessment. It contains 5 questions with 4 categories of answers (very satisfy- satisfy- dissatisfy - very dissatisfy). The proportion of each questions will be compared between groups

  4. Postoperative opioid consumption

    Time frame: Postoperative 30

    opioid consumption in morphine equivalent (mg) from PACU arrival to hospital discharge and from hospital discharge to 30 days post-surgery

  5. Intraoperative bradycardia

    Time frame: during surgery

    bradycardia incidence during surgery: defined as a heart rate < 40 per min with concomitant atropine administration (%)

  6. Postoperative hypoxemia incidence

    Time frame: Postoperative day 2

    hypoxemia incidence defined as therapeutic oxygen supplementation to maintain SpO2 > 95% from PACU arrival to postoperative day 2

  7. Health quality of life

    Time frame: Postoperative day 30

    Health quality of life on POD#30 with EuroQol5 dimension. Five-level version (EQ-5D-5L score) with visual analogic scale (for each question, you should answer among 5 propositions). The higher score, the better the quality of life of the patient.

  8. Early quality of recovery on POD#1

    Time frame: Postoperative day 1

    QoR15 at POD#1 depending on OFA vs OBA, whatever patient preferences. The minimum score is 0 and the maximum score is 150. The higher score, the better quality of recovery

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study 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)

Acronym: PERFECT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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