Opioid AnalgesiaPERFECTNCT06855641
Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery
A study testing Opioid based Anesthesia and opioid free anesthesia in people with Opioid Analgesia and Quality of Recovery (QoR-15), run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Analgesia, Quality of Recovery (QoR-15), Outcome Assessment
- What is being tested?
- Opioid based Anesthesia and opioid free anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2025to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Ronald Reagan medical center
Los Angeles, California, 90095
About this study
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)
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.
Read the 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.
- Conditions
- Opioid Analgesia, Quality of Recovery (QoR-15), Outcome Assessment, Opioid Free Anesthesia
- Being tested
- Opioid based Anesthesia, opioid free anesthesia
- Keywords
- opioids, quality of recovery, analgesia, moderate risk surgery, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid based AnesthesiaProcedure or surgery
in this group, patient will receive standard of care at UCLA including fentanyl administration during surgery
opioid free anesthesiaProcedure or surgery
In this group, patients will not receive any opioids intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Patient choose his analgesia type | Experimental | The patient here can decide which type of analgesia he/she wants ( OFA vs OBA) Receives: Procedure: Opioid based Anesthesia; Procedure: opioid free anesthesia |
| 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 Receives: Procedure: Opioid based Anesthesia; Procedure: opioid free anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1
Secondary outcomes (8)
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
Measured: Postoperative day 2
PONV incidence
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)
Measured: 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
Measured: 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
Measured: Postoperative 30
Intraoperative bradycardia
bradycardia incidence during surgery: defined as a heart rate < 40 per min with concomitant atropine administration (%)
Measured: during surgery
Postoperative hypoxemia incidence
hypoxemia incidence defined as therapeutic oxygen supplementation to maintain SpO2 > 95% from PACU arrival to postoperative day 2
Measured: 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.
Measured: 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
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start24 Mar 2025
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre P. Joosten, University of California, Los Angeles
- Investigators
- Alexandre JOOSTEN, MD PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855641
- Sponsor's protocol ID
- IRB-24-5789
- Acronym
- PERFECT
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40607110
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06855641
- Acronym / sponsor ID
- PERFECT / IRB-24-5789
- Conditions
- Opioid Analgesia, Quality of Recovery (QoR-15), Outcome Assessment, Opioid Free Anesthesia
- Keywords
- opioids, quality of recovery, analgesia, moderate risk surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The PERFECT trial is an interventional, pragmatic, partially randomized trial with factorial design.
| Arm | Type | Receives |
|---|---|---|
| Patient choose his analgesia type | Experimental | Procedure: Opioid based Anesthesia, Procedure: opioid free anesthesiaThe patient here can decide which type of analgesia he/she wants ( OFA vs OBA) |
| Patient does not choose his analgesia strategy | Active comparator | Procedure: Opioid based Anesthesia, Procedure: opioid free anesthesiaIf the patient does not choose his analgesia strategy, he/she will be randomized to OFA or OBA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Diagnosis of chronic pain
- Preoperative prescribed opioids
- Pregnancy or lactation.
- History of mental disorders.
- Contraindications to study drug (lidocaine, magnesium, dexmedetomidine, ketamine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid based Anesthesiain this group, patient will receive standard of care at UCLA including fentanyl administration during surgery | Procedure or surgery | Patient choose his analgesia type, Patient does not choose his analgesia strategy |
| opioid free anesthesiaIn this group, patients will not receive any opioids intraoperatively | Procedure or surgery | Patient choose his analgesia type, Patient does not choose his analgesia strategy |
Primary outcome
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
8 secondary outcomes
Quality of Recovery at postoperative day 2
Time frame: Postoperative day 2
PONV incidence
Time frame: Postoperative day 2
Anesthesia satisfaction
Time frame: Postoperative day 1
Postoperative opioid consumption
Time frame: Postoperative 30
Intraoperative bradycardia
Time frame: during surgery
Postoperative hypoxemia incidence
Time frame: Postoperative day 2
Health quality of life
Time frame: Postoperative day 30
Early quality of recovery on POD#1
Time frame: Postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 40607110Gricourt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre JOOSTEN, MD PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid based Anesthesia and opioid free anesthesia in people with Opioid Analgesia and Quality of Recovery (QoR-15), run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (QoR15) (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.