Opioid Analgesia, Quality of Recovery (QoR-15), Outcome Assessment, Opioid Free Anesthesia
Conditions
Keywords
opioids, quality of recovery, analgesia, moderate risk surgery, postoperative pain
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.
Interventions
PROCEDUREOpioid based Anesthesia
in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery
PROCEDUREopioid free anesthesia
In this group, patients will not receive any opioids intraoperatively
Sponsors
University of California, Los Angeles
Study design
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.
Intervention model description
The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery (QoR15) | 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
| Measure | Time frame | Description |
|---|---|---|
| PONV incidence | 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) |
| Anesthesia satisfaction | 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 |
| Postoperative opioid consumption | Postoperative 30 | opioid consumption in morphine equivalent (mg) from PACU arrival to hospital discharge and from hospital discharge to 30 days post-surgery |
| Quality of Recovery at postoperative day 2 | 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 hypoxemia incidence | Postoperative day 2 | hypoxemia incidence defined as therapeutic oxygen supplementation to maintain SpO2 \> 95% from PACU arrival to postoperative day 2 |
| Health quality of life | 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. |
| Early quality of recovery on POD#1 | 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 |
| Intraoperative bradycardia | during surgery | bradycardia incidence during surgery: defined as a heart rate \< 40 per min with concomitant atropine administration (%) |
Countries
United States
Outcome results
None listed