Back to resultsPrescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: (PROTECT)
Primary Purpose
Acute Pain, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescription by surgical team
Recommendation by surgical team
Sponsored by
About this trial
This is an interventional other trial for Acute Pain focused on measuring Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium
Eligibility Criteria
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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prescription Group for acetaminophen, NSAIDs, and magnesium
Over the Counter Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05370404
Brief Title
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Surgery
Keywords
Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prescription Group for acetaminophen, NSAIDs, and magnesium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Over the Counter Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prescription by surgical team
Intervention Description
The surgical team prescribes medications to the patient
Intervention Type
Other
Intervention Name(s)
Recommendation by surgical team
Intervention Description
The surgical team recommends the patient to take over-the-counter medications
Primary Outcome Measure Information:
Title
Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery
Description
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.
Time Frame
3 days following surgery discharge
Title
Patient use of acetaminophen within 3 days after discharge from surgery
Description
Patient-reported use of acetaminophen at any point in time within the first 3 days at home after discharge from surgery.
Time Frame
3 days following surgery discharge
Title
Patient use of NSAIDS within 3 days after discharge from surgery
Description
Patient-reported use of NSAIDs at any point in time within the first 3 days at home after discharge from surgery.
Time Frame
3 days following surgery discharge
Title
Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery
Description
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.
Time Frame
3 days following surgery discharge
Title
Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery
Description
Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery.
Time Frame
12-16 days following surgery discharge
Secondary Outcome Measure Information:
Title
Patient-reported consumption of opioid pills within 3 days after discharge from surgery
Description
The total amount of opioids consumed over days 0-3 after discharge from surgery will be compared between the two groups.
Time Frame
3 days following surgery discharge
Title
Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery
Description
The total amount of opioids consumed over the second week after discharge from surgery will be compared between the two groups.
Time Frame
12-16 days following surgery discharge
Title
Pain intensity at site of surgery 3 days following surgery discharge
Description
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.
Time Frame
3 days following surgery discharge
Title
Pain intensity at site of surgery as reported at 12-16 days following surgery discharge
Description
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.
Time Frame
3 days following surgery discharge
Title
Medication side effects within 3 days following surgery discharge
Description
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.
Time Frame
3 days following surgery discharge
Title
Patient satisfaction with pain treatment within 3 days following surgery discharge
Description
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.
Time Frame
3 days following surgery discharge
Title
Patient use of magnesium within 3 days after discharge from surgery
Description
Patient-reported use of magnesium at any point in time within the first 3 days at home after discharge from surgery.
Time Frame
3 days following surgery discharge
Title
Delayed magnesium use days as reported at 12-16 days after discharge from surgery
Description
Patient-reported use of magnesium in the second week after discharge from surgery.
Time Frame
12-16 days following surgery discharge
Other Pre-specified Outcome Measures:
Title
Opioid disposal
Description
Patient-reported disposal of opioids after completion of therapy
Time Frame
3-16 days following surgery discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendall Dubois
Phone
734-232-0324
Email
kendalld@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bicket, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendall Dubois
Phone
734-232-0324
Email
kendalld@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Mark Bicket, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
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