Knee ArthroscopyNO PAinNCT04566250
Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin)
A study testing Non-Opioid Prescription and Infographic in people with Knee Arthroscopy and Shoulder Arthroscopy, run by McMaster University at 3 sites in Canada.
Trial summary
This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Arthroscopy, Shoulder Arthroscopy
- What is being tested?
- Non-Opioid Prescription and Infographic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesCanada
- Study dates
- 24 Feb 2021to 1 Apr 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing outpatient knee or shoulder arthroscopy for any of the following procedures: ACL reconstruction (with or without LET), MPFL reconstruction (not including TTO), Chondroplasty, Meniscectomy, Meniscal repair Meniscal transplant, Microfracture, ACI, Fixation of unstable osteochondral lesion, Subacromial decompression, Rotator cuff repair, Shoulder stabilization, Superior capsule reconstruction, Biceps tenotomy/tenodesis, Capsular release, SLAP repair, Diagnostic arthroscopy, Irrigation and/or debridement, Loose body removal, Synovectomy
- Patients aged 18 years and older
- Patients who have the ability to speak, understand, and read English
- Provision of informed consent
Who cannot join
- Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
- Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
- Patients involved in another research study that requires a specific post-operative pain control medication regimen
- Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
- Patients who will undergo concomitant open surgery
- Patients who require overnight admission
Show all 11Show fewer
- Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone
- Patients diagnosed with renal disease or cardiac disease
- Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period
- Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
- Any other reason(s) the investigator feels is relevant for excluding the patient
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario, L8N2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
About this study
Official title: Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): a Randomized Controlled Trial
This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.
- Conditions
- Knee Arthroscopy, Shoulder Arthroscopy
- Being tested
- Non-Opioid Prescription and Infographic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Opioid Prescription and InfographicCombination product
The study intervention will involve 3 components:
- A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen).
- A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
- Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control.
| Study group | Role | What they receive |
|---|---|---|
| Non-Opioid Prescription and Infographic | Active comparator | The study intervention will involve 3 components:
1. A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 20mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). In the case of a Naproxen intolerance, a prescription for Meloxicam 15mg PO BID PRN x 60 tabs will be given.
2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
3. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control. Receives: Combination Product: Non-Opioid Prescription and Infographic |
| Standard of Care | Other | The control group is standard of care, which typically includes a prescription for an opioid. Receives: Combination Product: Non-Opioid Prescription and Infographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oral morphine equivalents (OMEs)
The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.
Measured: 6 weeks postoperatively
Secondary outcomes (5)
Pain (Visual Analogue Scale, VAS)
The VAS will include a 100mm line, on which patients will be asked to rate their average pain since their surgery.
Measured: 6 weeks postoperatively
Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)
We used the following modified question from the HCAHPS questionnaire related to satisfaction with pain relief, answered on a Likert scale (never, sometimes, usually, or always): "In the time after surgery, how often was your pain well controlled?"
Measured: 6 weeks postoperatively
OMEs Prescribed
As per the medication diary
Measured: 6 weeks postoperatively
Opioid Refills
As per the medication diary
Measured: 6 weeks postoperatively
Adverse Events
Adverse events, defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study, will be documented.
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start24 Feb 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Model description
- Eligible patients will be randomized using the centralized 24-hour computerized randomization system to allocate patients to the control (standard of care) or intervention (non-opioid prescription and infographic) group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Olufemi Ayeni, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566250
- Sponsor's protocol ID
- NOPain1111
- Acronym
- NO PAin
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing
Publications
NO PAin Investigators; Gazendam A, Ekhtiari S, Horner NS, Simunovic N, Khan M, de Sa DL, Madden K, Ayeni OR. Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1326-1335. doi: 10.1001/jama.2022.16844.
PubMed 36194219NO PAin Investigators. Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. BMC Musculoskelet Disord. 2021 May 22;22(1):471. doi: 10.1186/s12891-021-04354-x.
PubMed 34022863
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04566250
- Acronym / sponsor ID
- NO PAin / NOPain1111
- Conditions
- Knee Arthroscopy, Shoulder Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, The Physicians' Services Incorporated Foundation
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 28 Sep 2020 (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.
This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized using the centralized 24-hour computerized randomization system to allocate patients to the control (standard of care) or intervention (non-opioid prescription and infographic) group.
| Arm | Type | Receives |
|---|---|---|
| Non-Opioid Prescription and Infographic | Active comparator | Combination Product: Non-Opioid Prescription and InfographicThe study intervention will involve 3 components: 1. A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 20mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). In the case of a Naproxen intolerance, a prescription for Meloxicam 15mg PO BID PRN x 60 tabs will be given. 2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription. 3. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control. |
| Standard of Care | Other | Combination Product: Non-Opioid Prescription and InfographicThe control group is standard of care, which typically includes a prescription for an opioid. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing outpatient knee or shoulder arthroscopy for any of the following procedures: ACL reconstruction (with or without LET), MPFL reconstruction (not including TTO), Chondroplasty, Meniscectomy, Meniscal repair Meniscal transplant, Microfracture, ACI, Fixation of unstable osteochondral lesion, Subacromial decompression, Rotator cuff repair, Shoulder stabilization, Superior capsule reconstruction, Biceps tenotomy/tenodesis, Capsular release, SLAP repair, Diagnostic arthroscopy, Irrigation and/or debridement, Loose body removal, Synovectomy
- Patients aged 18 years and older
- Patients who have the ability to speak, understand, and read English
- Provision of informed consent
Key exclusion criteria (11 listed)
- Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
- Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
- Patients involved in another research study that requires a specific post-operative pain control medication regimen
- Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
- Patients who will undergo concomitant open surgery
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 |
|---|---|---|
| Non-Opioid Prescription and InfographicThe study intervention will involve 3 components: 1. A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). 2. A limited opioid "rescue prescription": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription. 3. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control. | Combination product | Non-Opioid Prescription and Infographic, Standard of Care |
Primary outcome
Total oral morphine equivalents (OMEs)
Time frame: 6 weeks postoperatively
The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.
5 secondary outcomes
Pain (Visual Analogue Scale, VAS)
Time frame: 6 weeks postoperatively
Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)
Time frame: 6 weeks postoperatively
OMEs Prescribed
Time frame: 6 weeks postoperatively
Opioid Refills
Time frame: 6 weeks postoperatively
Adverse Events
Time frame: 6 weeks postoperatively
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 21 Nov 2024.
- Derived from this study: PubMed 36194219NO PAin Investigators; Gazendam A, Ekhtiari S, Horner NS, Simunovic N, Khan M, de Sa DL, Madden K, Ayeni OR. Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1326-1335. doi: 10.1001/jama.2022.16844.
- Derived from this study: PubMed 34022863NO PAin Investigators. Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. BMC Musculoskelet Disord. 2021 May 22;22(1):471. doi: 10.1186/s12891-021-04354-x.
- Individual participant dataSharing planned: No. No data sharing
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Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Opioid Prescription and Infographic in people with Knee Arthroscopy and Shoulder Arthroscopy, run by McMaster University at 3 sites 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 4 inclusion and 11 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 21 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 3 sites 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?
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?
Total oral morphine equivalents (OMEs) (time frame: 6 weeks postoperatively). 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 NCT04566250, which also lists 2 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 21 Nov 2024.