Acute Pain, Surgery
Conditions
Keywords
Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium
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.
Interventions
OTHERPrescription by surgical team
The surgical team prescribes medications to the patient
OTHERRecommendation by surgical team
The surgical team recommends the patient to take over-the-counter medications
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed acetaminophen and NSAID use as reported at 12-16 days after discharge from surgery | 12-16 days following surgery discharge | Patient-reported use of acetaminophen and/or NSAIDs in the second week after discharge from surgery. |
| Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery | 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. |
| Patient use of acetaminophen within 3 days after discharge from surgery | 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. |
| Patient use of NSAIDS within 3 days after discharge from surgery | 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. |
| Patient use of acetaminophen and NSAID with opioid within 3 days after discharge from surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication side effects within 3 days following surgery discharge | 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 | 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. |
| Delayed magnesium use days as reported at 12-16 days after discharge from surgery | 12-16 days following surgery discharge | Patient-reported use of magnesium in the second week after discharge from surgery. |
| Patient use of magnesium within 3 days after discharge from surgery | 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. |
| Patient-reported consumption of opioid pills within 3 days after discharge from surgery | 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. |
| Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery | 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. |
| Pain intensity at site of surgery 3 days following surgery discharge | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid disposal | 3-16 days following surgery discharge | Patient-reported disposal of opioids after completion of therapy |
Countries
United States
Outcome results
None listed