Outpatient SurgeryPhase 2/3NCT04254679
Pilot Trial: Postoperative Opioid-free Analgesia
A Phase 2/3 study testing Opioid analgesics and Non-opioid analgesics in people with Outpatient Surgery and Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outpatient Surgery, Abdominal Surgery, Breast Surgery
- What is being tested?
- Opioid analgesics and Non-opioid analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2020to 3 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients (>18 yo) undergoing outpatient surgery
- Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
- Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)
Who cannot join
- All patients
- Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
- Contraindications to any of the drugs used in the trial
- Difficult to be reached after surgery
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial
North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.
Read the detailed description
This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.
- Conditions
- Outpatient Surgery, Abdominal Surgery, Breast Surgery
- Being tested
- Opioid analgesics, Non-opioid analgesics
- Keywords
- Opioids, Surgery, Postoperative Period, Postoperative Pain, Analgesia, Pain Management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid analgesicsDrug
Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
Non-opioid analgesicsDrug
Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.
| Study group | Role | What they receive |
|---|---|---|
| Opioid analgesia | Experimental | Not described Receives: Drug: Opioid analgesics |
| Opioid-free analgesia | Active comparator | Not described Receives: Drug: Non-opioid analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Screened Participants Who Were Eligible to Participate in the Study
At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Measured: 4 months
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).
Measured: 4 months
Percentage of Eligible Patients Agreeing to Participate
At least 50% of eligible patients agree to participate in the study and are randomized.
Measured: 4 months
Percentage of Randomized Patients Complying With Allocated Treatment
At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).
Measured: 4 months
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
At least 80% of the randomized patients complete outcome assessment at 30 days after surgery.
Measured: 4 months
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.
Measured: 4 months
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).
Measured: 4 months
Secondary outcomes (10)
Postoperative Pain
Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes.
Measured: 30 days.
Time to Stopping Pain Medication
The time to the first report of stopping the use of pain medication.
Measured: 30 days.
Postoperative Health Status
Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured.
Measured: Weeks 1, 2, 3 and 4 after surgery.
Opioid Side-effects
Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain.
The reported rates indicate the number of reported events per period of evaluation.
Measured: Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery
Rate of Opioid Misuse
Measured using the Prescription Opioid Misuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to >1 question indicates the patient exhibits prescription opioid misuse.
Measured: 4 weeks
Postoperative Complications Classification
Graded by severity using the Dindo-Clavien classification. This system grades complications according to the therapy needed for treatment (grades I to IV, best to worse).
Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.
Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IIIa - intervention not under general anaesthetic Grade IIIb - intervention under general anaesthetic
Measured: 30 days.
Rate of Unplanned Healthcare Utilization
Emergency department visits, hospital readmissions.
Measured: 30 days.
Rate of Adverse Drug Events
Obtained from spontaneous patient reporting (Trigger question "Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?"). Events were coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system.
Measured: 30 days after surgery
Rate of Prolonged Opioid Use
Filling of opioid prescriptions up to 3 months after surgery.
Measured: 3 months
Comprehensive Complication Index at 30-day
Measured using the Comprehensive Complication Index score at 30 after surgery. The score ranges from 0 to 100; higher scores indicate greater severity of complications.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start29 Jan 2020
- Primary completion20 Sep 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outpatient SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a parallel, two-group, assessor-blind, pilot randomized trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Responsible party
- Principal investigator, Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254679
- Sponsor's protocol ID
- MUHC REB 2020-5965
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2020
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Do U, El-Kefraoui C, Pook M, Balvardi S, Barone N, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF Jr; McGill Better Opioid Prescribing Collaboration; Alhashemi M, Antoun A, Barkun JS, Brecht KM, Chaudhury PK, Deckelbaum D, Di Lena E, Dumitra S, Elhaj H, Fata P, Fleiszer D, Fried GM, Grushka J, Kaneva P, Khwaja K, Lapointe-Gagner M, McKendy KM, Meguerditchian AN, Meterissian SH, Montgomery H, Rajabiyazdi F, Safa N, Touma N, Tremblay F. Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221430. doi: 10.1001/jamanetworkopen.2022.21430.
PubMed 35849399
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04254679
- Acronym / sponsor ID
- MUHC REB 2020-5965
- Conditions
- Outpatient Surgery, Abdominal Surgery, Breast Surgery
- Keywords
- Opioids, Surgery, Postoperative Period, Postoperative Pain, Analgesia, Pain Management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.
Detailed description
This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a parallel, two-group, assessor-blind, pilot randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Opioid analgesia | Experimental | Drug: Opioid analgesics |
| Opioid-free analgesia | Active comparator | Drug: Non-opioid analgesics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 yo) undergoing outpatient surgery
- Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
- Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)
Key exclusion criteria (5 listed)
- All patients
- Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
- Contraindications to any of the drugs used in the trial
- Difficult to be reached after surgery
- Inability to provide written informed consent
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 analgesicsCurrent standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. | Drug | Opioid analgesia |
| Non-opioid analgesicsPrescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference. | Drug | Opioid-free analgesia |
Primary outcome
Percentage of Screened Participants Who Were Eligible to Participate in the Study
Time frame: 4 months
At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
Time frame: 4 months
At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).
Percentage of Eligible Patients Agreeing to Participate
Time frame: 4 months
At least 50% of eligible patients agree to participate in the study and are randomized.
Percentage of Randomized Patients Complying With Allocated Treatment
Time frame: 4 months
At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
Time frame: 4 months
At least 80% of the randomized patients complete outcome assessment at 30 days after surgery.
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
Time frame: 4 months
Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
Time frame: 4 months
Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).
10 secondary outcomes
Postoperative Pain
Time frame: 30 days.
Time to Stopping Pain Medication
Time frame: 30 days.
Postoperative Health Status
Time frame: Weeks 1, 2, 3 and 4 after surgery.
Opioid Side-effects
Time frame: Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery
Rate of Opioid Misuse
Time frame: 4 weeks
Postoperative Complications Classification
Time frame: 30 days.
Rate of Unplanned Healthcare Utilization
Time frame: 30 days.
Rate of Adverse Drug Events
Time frame: 30 days after surgery
Rate of Prolonged Opioid Use
Time frame: 3 months
Comprehensive Complication Index at 30-day
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35849399Do U, El-Kefraoui C, Pook M, Balvardi S, Barone N, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF Jr; McGill Better Opioid Prescribing Collaboration; Alhashemi M, Antoun A, Barkun JS, Brecht KM, Chaudhury PK, Deckelbaum D, Di Lena E, Dumitra S, Elhaj H, Fata P, Fleiszer D, Fried GM, Grushka J, Kaneva P, Khwaja K, Lapointe-Gagner M, McKendy KM, Meguerditchian AN, Meterissian SH, Montgomery H, Rajabiyazdi F, Safa N, Touma N, Tremblay F. Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221430. doi: 10.1001/jamanetworkopen.2022.21430.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Opioid analgesics and Non-opioid analgesics in people with Outpatient Surgery and Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 5 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Screened Participants Who Were Eligible to Participate in the Study (time frame: 4 months). The study lists 7 primary outcomes in all. 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 NCT04254679, 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 20 Nov 2024.