Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:

Study Overview
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Brief Summary
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This is a research project in which two standard of care practices will be evaluated to examine the difference in outcomes. The goal is to improve patient care and safety. One group will receive prescriptions for acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and magnesium. The other group will receive the recommendation to take acetaminophen, NSAIDs, and magnesium as over-the-counter drugs in the same dosage as the prescription group. The same doses and routes for non-opioid medications will be used in both groups.

Official Title
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Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: A Project on Non-Opioid Pain Medication Use After Discharge From Elective Surgery

Conditions
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Acute Pain, Surgery

Intervention / Treatment
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* Other: Prescription by surgical team
* Other: Recommendation by surgical team


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery Exclusion Criteria: Contraindications to taking acetaminophen or NSAIDs Significant analgesic medication use before surgery Inability to receive emails or phone calls for follow up assessment Patients who have reoperation, another surgery, or experience complications within 14 days after surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prescription Group for acetaminophen, NSAIDs, and magnesium<br>Participants will receive prescriptions from the surgical team for non-opioid pain medications to take at home after discharge from surgery. The non-opioid pain medications will be acetaminophen 1000 milligram (mg) four times a day (qid) for 3 days then as needed (prn) pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain. | Other: Prescription by surgical team<br>* The surgical team prescribes medications to the patient<br>|
| Active Comparator: Over the Counter Group<br>Participants will receive a recommendation from the surgical team to take over-the-counter non-opioid pain medications at home after discharge from surgery. The non-opioid pain medications will be acetaminophen 1000 mg qid for 3 days then prn pain, ibuprofen 600 mg qid for 3 days then prn, and magnesium oxide 400 mg daily prn pain. | Other: Recommendation by surgical team<br>* The surgical team recommends the patient to take over-the-counter medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery | Patient report of the number of doses within the first 3 days of the use of both acetaminophen and NSAID at home after discharge from surgery. Patients are anticipated to take up to 4 doses of acetaminophen and NSAIDs per day. Over 3 days, patients would be anticipated to take a maximum of 12 doses. This outcome is a count that ranges from 0 (no doses of acetaminophen plus NSAIDs) to 12. | 3 days following surgery discharge | 
| Patient use of acetaminophen within 3 days after discharge from surgery | Patient-reported use of acetaminophen at any point in time within the first 3 days at home after discharge from surgery. | 3 days following surgery discharge | 
| Patient use of NSAIDS within 3 days after discharge from surgery | Patient-reported use of NSAIDs at any point in time within the first 3 days at home after discharge from surgery. | 3 days following surgery discharge | 
| Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery | Patient-reported use of both acetaminophen and NSAID on every day oral pain medication is taken within the first 3 days at home after discharge from surgery. | 3 days following surgery discharge | 
| Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery | Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery. | 12-16 days following surgery discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported consumption of opioid pills within 3 days after discharge from surgery | The total amount of opioids consumed over days 0-3 after discharge from surgery will be compared between the two groups. | 3 days following surgery discharge | 
| Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery | The total amount of opioids consumed over the second week after discharge from surgery will be compared between the two groups. | 12-16 days following surgery discharge | 
| Pain intensity at site of surgery 3 days following surgery discharge | This is a one question survey in which the participants are asked to rate the pain at the site of the surgery that best describes the pain from a scale of 0 (no pain) to 10 (pain is the worst). Trends in worst pain intensity over days 0-3 after discharge from surgery will be compared between the two groups. | 3 days following surgery discharge | 
| Pain intensity at site of surgery as reported at 12-16 days following surgery discharge | This is a one question survey in which the participants are asked to rate the pain at the site of the surgery that best describes the pain from a scale of 0 (no pain) to 10 (pain is the worst). Trends in worst pain intensity over the second week after discharge from surgery will be compared between the two groups. | 3 days following surgery discharge | 
| Medication side effects within 3 days following surgery discharge | Patient report of common analgesic related side effects will be measured using the Medicare symptom checklist. Composite report of any side effect over days 0-3 after discharge from surgery will be compared between the two groups. | 3 days following surgery discharge | 
| Patient satisfaction with pain treatment within 3 days following surgery discharge | This is a one question survey in which the participants are asked to rate the satisfaction for pain management with a scale from very dissatisfied to very satisfied. Patient report of overall satisfaction with the postoperative pain treatment over days 0-3 after discharge from surgery will be compared between the two groups. | 3 days following surgery discharge | 
| Patient use of magnesium within 3 days after discharge from surgery | Patient-reported use of magnesium at any point in time within the first 3 days at home after discharge from surgery. | 3 days following surgery discharge | 
| Delayed magnesium use days as reported at 12-16 days after discharge from surgery | Patient-reported use of magnesium in the second week after discharge from surgery. | 12-16 days following surgery discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium