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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient choose his analgesia type | Experimental | The patient here can decide which type of analgesia he/she wants ( OFA vs OBA) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid based Anesthesia | Procedure | in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery (QoR15) | 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 | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery at 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 | Postoperative day 2 |
| PONV incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre JOOSTEN, MD PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| UCLA Ronald Reagan medical center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40607110 | Derived | Gricourt Y, Boulos NM, Delaporte A, Alexander B, Besada S, Bakhit R, Toukhtarian A, Neuman I, Pearce D, Nourian MM, Chebishian A, Zhou A, Boktor J, Mayanja D, Grogan T, Boldt D, Cannesson M, Forget P, Joosten A. Patient preference for intraoperative opioid use and early recovery after noncardiac surgery: protocol for a randomised factorial design trial of opioid-free versus opioid-based anaesthesia (the PERFECT trial). BJA Open. 2025 Jun 18;15:100420. doi: 10.1016/j.bjao.2025.100420. eCollection 2025 Sep. |
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The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.
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quality of recovery will be done by research coordinators and research students ( undergraduate students) not involved in patient care.
| opioid free anesthesia | Procedure | In this group, patients will not receive any opioids intraoperatively |
|
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) |
| Postoperative day 2 |
| Anesthesia satisfaction | 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 | Postoperative day 1 |
| Postoperative opioid consumption | opioid consumption in morphine equivalent (mg) from PACU arrival to hospital discharge and from hospital discharge to 30 days post-surgery | Postoperative 30 |
| Intraoperative bradycardia | bradycardia incidence during surgery: defined as a heart rate < 40 per min with concomitant atropine administration (%) | during surgery |
| Postoperative hypoxemia incidence | hypoxemia incidence defined as therapeutic oxygen supplementation to maintain SpO2 > 95% from PACU arrival to postoperative day 2 | Postoperative day 2 |
| Health quality of life | 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. | Postoperative day 30 |
| Early quality of recovery on POD#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 | Postoperative day 1 |
| Los Angeles |
| California |
| 90095 |
| United States |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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