Post Operative PainPAIN-AltNCT06507345
Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery
A study testing Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs] and Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs] in people with Post Operative Pain and Opioid Analgesic Adverse Reaction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Opioid Analgesic Adverse Reaction, Surgery
- What is being tested?
- Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs] and Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteCanada
- Study dates
- 26 Nov 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Undergoing mastectomy (i.e., total, modified radical, radical, or skin/nipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)
- Planned discharge on the day of the operation.
Who cannot join
- Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous/flap-based (often leads to higher levels of pain and analgesia requirements)
- Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)
- Taking opioids preoperatively
- Cognitive impairment precluding patient-reported outcome assessment
- Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical [e.g., intra-operative complications] or non-medical reasons [e.g., lack of support at home]).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre (Glen Site)
Montreal, Quebec, H4A 3J1
Samin Shirzadi, MD, MPH, 6475643377, samin.shirzadi@rimuhc.ca
Karine Roversi, PhD, 4384935427
About this study
Official title: Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)
North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids?
The proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.
- Conditions
- Post Operative Pain, Opioid Analgesic Adverse Reaction, Surgery, Postoperative Pain, Breast Disease
- Being tested
- Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs], Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]
- Keywords
- Surgery, Postoperative analgesia, Breast surgery, Opioids, Postoperative pain, Postoperative care
- Medical subject headings
- Pain, Postoperative, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs]Other
In line with current standard care, discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs given at regularly scheduled intervals) and opioid tablets 'as needed' for breakthrough pain (i.e., pain that erupts while patients are already taking analgesics). Non-pharmacological pain interventions (i.e., icepacks, music, meditation.) may be recommended by some surgeons as part of standard practice. Given the pragmatic nature of the trial, the specific around-the-clock analgesia and rescue opioid regimens and other non-pharmacological interventions will be determined by the patient's surgeon discretion considering the breast procedure undertaken, co-morbidities, and patient preference.
Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]Other
Discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs). In case of breakthrough pain, rescue analgesia may be provided by (1) using evidence-based non-pharmacological pain interventions (i.e., icepacks, music, and meditation), (2) adding non-opioid drugs not included in the initial regimen, or (3) switching drugs targeting individual variances in analgesia response. The specific around-the-clock and rescue OFA regimens will be determined by the patient's surgeon considering the type of procedure, co-morbidities, and patient preference.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Analgesia (OA) | Active comparator | Not described Receives: Other: Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs] |
| Opioid-Free Analgesia (OFA) | Experimental | Not described Receives: Other: Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain intensity is measured across four domains (worst, least, on average, and currently). Aggregated scores of pain intensity range from 0-10, with higher scores representing worse outcomes.
Measured: Postoperative days 1 to 7.
Pain interference
Pain interference will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain interference is measured across seven domains (mood, work, general activity, walking, relationships, enjoyment of life, and sleep). Aggregated scores of pain interference range from 0-10, with higher scores representing worse outcomes.
Measured: Postoperative days 1 to 7.
Secondary outcomes (9)
Adverse drug events
Data regarding adverse drug events will be obtained from an author-generated questionnaire and from medical records.
Adverse events will be coded using the MedDRA coding dictionary, grade their severity according to the Common Terminology Criteria for Adverse Events (CTCAE) (1-Mild to 5-Death) and assess potential causality using the WHO/UMC system (certain, probable/likely, possible, unlikely, conditional/unclassified, or un-assessable/un-classifiable).
Measured: Up to 30 days after surgery.
Time to stopping pain medication
The time to the first report of stopping the use of pain medication will be calculated based on information obtained via questionnaires responded on day 1 to 7, and weeks 2, 3 and 4 after surgery. The time to stopping pain medication will be calculated based on the first of two consecutive reports of 'no pain medication'.
Measured: Up to 30 days after surgery.
Physical and Mental Health Status
This outcome will be assessed using PROMIS-29, a generic health survey, which assesses 8 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity).
Measured: Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.
Opioid misuse
This outcome will be assessed using Prescription Opioid Misuse Index which is a 6-item questionnaire 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.
Measured: Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.
Satisfaction with pain management
Patients will be asked to rate their overall satisfaction with the pain treatment received after discharge using a question adapted from the American Pain Society Patient Outcome Questionnaire: Please rate your satisfaction with the pain treatment that you received since hospital discharge (Scale 0-10; Extremely Dissatisfied-Extremely Satisfied).
Measured: Postoperative day 7.
30-day postoperative complications
Data regarding postoperative complications will be obtained from medical records and 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). Complications within 30 days after surgery will be recorded. In addition, the Comprehensive Complication Index (CCI) will be generated for each patient to summarize the complete spectrum of postoperative complications and their severity in a single score ranging from 0 to 100 (best to worse).
Measured: Up to 30 days after surgery.
30-day unplanned healthcare utilization
Unplanned healthcare utilization (ED visits and unplanned hospital readmissions) within 30 days after surgery will be extracted from the electronic medical records and patient self-report.
Measured: Up to 30 days after surgery.
Chronic postsurgical pain
Chronic postsurgical pain will be defined according to ICD-11 as 'pain that develops after a surgical procedure and persists at least 3 months after surgery'. Patients will be asked about chronic pain at 3 and 6 months after surgery using a question modified from the International Pain Outcomes (IPO) Questionnaire. To have a baseline comparator, a similar question will be asked to inquire about the presence of chronic pain preoperatively.
Measured: Up to 6 months after surgery.
Persistent opioid use
The filling of opioid prescriptions will be monitored for 6 months. According to previous literature, persistent opioid use will be defined when a patient has an opioid prescription filled between 90 and 180 days after surgery. Data is obtained via provincial pharmacy records.
Measured: Up to 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start26 Nov 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Julio F Fiore Jr, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Julio Flavio Fiore, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507345
- Sponsor's protocol ID
- 2024-10253
- Acronym
- PAIN-Alt
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.
PubMed 35717988Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
PubMed 31563269Do 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 35849399Do U, Pook M, Najafi T, Rajabiyazdi F, El-Kefraoui C, Balvardi S, Barone N, Elhaj H, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF; McGill Better Opioid Prescribing (MBOP) Collaboration. S110-Opioid-free analgesia after outpatient general surgery: A qualitative study focused on the perspectives of patients and clinicians involved in a pilot trial. Surg Endosc. 2023 Mar;37(3):2269-2280. doi: 10.1007/s00464-022-09472-8. Epub 2022 Aug 2.
PubMed 35918552Fiore JF Jr, Shirzadi S, Roversi K, Prakash I, Wong S, Meterissian S, Meguerditchian AN, Desbiens C, Rivard J, Delisle M, Findlay-Shirras L, Abou Khalil J, Maciver A, Quan ML, Verreault K, Johnston S, Feldman L, McDonald EG; Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN-Alt) Collaboration. Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol. BMJ Open. 2025 Nov 4;15(11):e107258. doi: 10.1136/bmjopen-2025-107258.
PubMed 41193191
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)
- ClinicalTrials.gov ID
- NCT06507345
- Acronym / sponsor ID
- PAIN-Alt / 2024-10253
- Conditions
- Post Operative Pain, Opioid Analgesic Adverse Reaction, Surgery, Postoperative Pain, Breast Disease
- Keywords
- Surgery, Postoperative analgesia, Breast surgery, Opioids, Postoperative pain, Postoperative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Jul 2024 (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.
North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids?
The proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Analgesia (OA) | Active comparator | Other: Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs] |
| Opioid-Free Analgesia (OFA) | Experimental | Other: Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing mastectomy (i.e., total, modified radical, radical, or skin/nipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)
- Planned discharge on the day of the operation.
Key exclusion criteria (5 listed)
- Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous/flap-based (often leads to higher levels of pain and analgesia requirements)
- Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy/hypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)
- Taking opioids preoperatively
- Cognitive impairment precluding patient-reported outcome assessment
- Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical [e.g., intra-operative complications] or non-medical reasons [e.g., lack of support at home]).
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 Analgesia (OA) [Multimodal analgesia including opioid drugs]In line with current standard care, discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs given at regularly scheduled intervals) and opioid tablets 'as needed' for breakthrough pain (i.e., pain that erupts while patients are already taking analgesics). Non-pharmacological pain interventions (i.e., icepacks, music, meditation.) may be recommended by some surgeons as part of standard practice. Given the pragmatic nature of the trial, the specific around-the-clock analgesia and rescue opioid regimens and other non-pharmacological interventions will be determined by the patient's surgeon discretion considering the breast procedure undertaken, co-morbidities, and patient preference. | Other | Opioid Analgesia (OA) |
| Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs]Discharge prescriptions for this group will include around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs). In case of breakthrough pain, rescue analgesia may be provided by (1) using evidence-based non-pharmacological pain interventions (i.e., icepacks, music, and meditation), (2) adding non-opioid drugs not included in the initial regimen, or (3) switching drugs targeting individual variances in analgesia response. The specific around-the-clock and rescue OFA regimens will be determined by the patient's surgeon considering the type of procedure, co-morbidities, and patient preference. | Other | Opioid-Free Analgesia (OFA) |
Primary outcome
Pain intensity
Time frame: Postoperative days 1 to 7.
Pain intensity will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain intensity is measured across four domains (worst, least, on average, and currently). Aggregated scores of pain intensity range from 0-10, with higher scores representing worse outcomes.
Pain interference
Time frame: Postoperative days 1 to 7.
Pain interference will be measured using the Brief Pain Inventory-Short Form (BPI), a self-reported pain questionnaire developed by the World Health Organization (WHO). In this questionnaire, pain interference is measured across seven domains (mood, work, general activity, walking, relationships, enjoyment of life, and sleep). Aggregated scores of pain interference range from 0-10, with higher scores representing worse outcomes.
9 secondary outcomes
Adverse drug events
Time frame: Up to 30 days after surgery.
Time to stopping pain medication
Time frame: Up to 30 days after surgery.
Physical and Mental Health Status
Time frame: Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.
Opioid misuse
Time frame: Postoperative weeks 1, 2, 3, and 4, postoperative month 3 and 6.
Satisfaction with pain management
Time frame: Postoperative day 7.
30-day postoperative complications
Time frame: Up to 30 days after surgery.
30-day unplanned healthcare utilization
Time frame: Up to 30 days after surgery.
Chronic postsurgical pain
Time frame: Up to 6 months after surgery.
Persistent opioid use
Time frame: Up to 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 35717988Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)00582-7.
- Background: PubMed 31563269Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
- Background: 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.
- Background: PubMed 35918552Do U, Pook M, Najafi T, Rajabiyazdi F, El-Kefraoui C, Balvardi S, Barone N, Elhaj H, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF; McGill Better Opioid Prescribing (MBOP) Collaboration. S110-Opioid-free analgesia after outpatient general surgery: A qualitative study focused on the perspectives of patients and clinicians involved in a pilot trial. Surg Endosc. 2023 Mar;37(3):2269-2280. doi: 10.1007/s00464-022-09472-8. Epub 2022 Aug 2.
- Derived from this study: PubMed 41193191Fiore JF Jr, Shirzadi S, Roversi K, Prakash I, Wong S, Meterissian S, Meguerditchian AN, Desbiens C, Rivard J, Delisle M, Findlay-Shirras L, Abou Khalil J, Maciver A, Quan ML, Verreault K, Johnston S, Feldman L, McDonald EG; Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN-Alt) Collaboration. Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol. BMJ Open. 2025 Nov 4;15(11):e107258. doi: 10.1136/bmjopen-2025-107258.
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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.
Julio Flavio Fiore, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Analgesia (OA) [Multimodal analgesia including opioid drugs] and Opioid-Free Analgesia (OFA) [Multimodal analgesia not including opioid drugs] in people with Post Operative Pain and Opioid Analgesic Adverse Reaction, 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 2 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samin Shirzadi, MD, MPH (6475643377, samin.shirzadi@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Postoperative days 1 to 7.). The study lists 2 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 NCT06507345, which also lists 5 linked publications.
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 13 Jan 2025.