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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
| The Physicians' Services Incorporated Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Opioid Prescription and Infographic | Active Comparator | The study intervention will involve 3 components:
|
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| Standard of Care | Other | The control group is standard of care, which typically includes a prescription for an opioid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Opioid Prescription and Infographic | Combination Product | The study intervention will involve 3 components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Total oral morphine equivalents (OMEs) | The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary. | 6 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks postoperatively |
| Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8N2X2 | Canada | ||
| McMaster University Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36194219 | Derived | 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. | |
| 34022863 |
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No data sharing
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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.
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Given that patients in the intervention group will receive a pamphlet explaining how to use their prescription allocation, patient blinding is not feasible. Surgeons cannot be blinded as they will need to sign the prescriptions and provide any necessary advice about the medications being prescribed. Outcome assessors and data analysts will be blinded.
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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?" |
| 6 weeks postoperatively |
| OMEs Prescribed | As per the medication diary | 6 weeks postoperatively |
| Opioid Refills | As per the medication diary | 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. | 6 weeks postoperatively |
| Hamilton |
| Ontario |
| L8N3Z5 |
| Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
| NO 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. |