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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Acute Pain
• Intervention / Treatment: Other: Prescription by surgical team; Other: Recommendation by surgical team

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prescription Group for acetaminophen, NSAIDs, and magnesium; 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; The surgical team prescribes medications to the patient
Active Comparator: Over the Counter Group; 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; The surgical team recommends the patient to take over-the-counter medications

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid disposal	Patient-reported disposal of opioids after completion of therapy	3-16 days following surgery discharge

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Mark Bicket, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Acetaminophen; Magnesium; Surveys; Opioids; NSAIDS; Medications after surgery; Elective outpatient surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: HUM00203454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No