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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Quality of recovery (QoR15)
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
quality of recovery will be done by research coordinators and research students ( undergraduate students) not involved in patient care.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patient choose his analgesia type
The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)
Intervention: Opioid based Anesthesia (Procedure)
Patient choose his analgesia type
The patient here can decide which type of analgesia he/she wants ( OFA vs OBA)
Intervention: opioid free anesthesia (Procedure)
Patient does not choose his analgesia strategy
If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA
Intervention: Opioid based Anesthesia (Procedure)
Patient does not choose his analgesia strategy
If the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA
Intervention: opioid free anesthesia (Procedure)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Alexandre P. Joosten
Associate Professor
University of California, Los Angeles
