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

Surgery Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370404
• Other study ID #: HUM00203454
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Kendall Dubois
• Phone: 734-232-0324
• Email: kendalld[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Surgery

Intervention

Other:
• Prescription by surgical team
The surgical team prescribes medications to the patient
• Recommendation by surgical team
The surgical team recommends the patient to take over-the-counter medications

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid disposal	Patient-reported disposal of opioids after completion of therapy	3-16 days following surgery discharge
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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