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Completed

NCT Number: NCT05370404

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prescription by surgical team

Other

The surgical team prescribes medications to the patient

Recommendation by surgical team

Other

The surgical team recommends the patient to take over-the-counter medications

Primary outcomes

  1. Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    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.

  2. Patient use of acetaminophen within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    Patient-reported use of acetaminophen at any point in time within the first 3 days at home after discharge from surgery.

  3. Patient use of NSAIDS within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    Patient-reported use of NSAIDs at any point in time within the first 3 days at home after discharge from surgery.

  4. Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    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.

  5. Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery

    Time frame: 12-16 days following surgery discharge

    Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery.

Secondary outcomes

  1. Patient-reported consumption of opioid pills within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    The total amount of opioids consumed over days 0-3 after discharge from surgery will be compared between the two groups.

  2. Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery

    Time frame: 12-16 days following surgery discharge

    The total amount of opioids consumed over the second week after discharge from surgery will be compared between the two groups.

  3. Pain intensity at site of surgery 3 days following surgery discharge

    Time frame: 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.

  4. Pain intensity at site of surgery as reported at 12-16 days following surgery discharge

    Time frame: 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 the second week after discharge from surgery will be compared between the two groups.

  5. Medication side effects within 3 days following surgery discharge

    Time frame: 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.

  6. Patient satisfaction with pain treatment within 3 days following surgery discharge

    Time frame: 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.

  7. Patient use of magnesium within 3 days after discharge from surgery

    Time frame: 3 days following surgery discharge

    Patient-reported use of magnesium at any point in time within the first 3 days at home after discharge from surgery.

  8. Delayed magnesium use days as reported at 12-16 days after discharge from surgery

    Time frame: 12-16 days following surgery discharge

    Patient-reported use of magnesium in the second week after discharge from surgery.

Other outcomes

  1. Opioid disposal

    Time frame: 3-16 days following surgery discharge

    Patient-reported disposal of opioids after completion of therapy

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Acronym: PROTECT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 11, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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