Acute PainPROTECTNCT05370404
Prescribing Vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients with Postoperative Pain:
A study testing Prescription by surgical team and Recommendation by surgical team in people with Acute Pain and Surgery, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Surgery
- What is being tested?
- Prescription by surgical team and Recommendation by surgical team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acute Pain, Surgery
- Being tested
- Prescription by surgical team, Recommendation by surgical team
- Keywords
- Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription by surgical teamOther
The surgical team prescribes medications to the patient
Recommendation by surgical teamOther
The surgical team recommends the patient to take over-the-counter medications
| Study group | Role | What they receive |
|---|---|---|
| Prescription Group for acetaminophen, NSAIDs, and magnesium | Active comparator | 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. Receives: Other: Prescription by surgical team |
| Over the Counter Group | Active comparator | 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. Receives: Other: Recommendation by surgical team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-16 days following surgery discharge
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-16 days following surgery discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start30 Sep 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Bicket, MD, PhD, University of Michigan
- Investigators
- Mark Bicket, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370404
- Sponsor's protocol ID
- HUM00203454
- Acronym
- PROTECT
- Status last verified
- Dec 2024
- First submitted
- 6 May 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370404
- Acronym / sponsor ID
- PROTECT / HUM00203454
- Conditions
- Acute Pain, Surgery
- Keywords
- Medications after surgery, Surveys, Acetaminophen, NSAIDS, Opioids, Elective outpatient surgery, Magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription Group for acetaminophen, NSAIDs, and magnesium | Active comparator | Other: Prescription by surgical teamParticipants 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. |
| Over the Counter Group | Active comparator | Other: Recommendation by surgical teamParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription by surgical teamThe surgical team prescribes medications to the patient | Other | Prescription Group for acetaminophen, NSAIDs, and magnesium |
| Recommendation by surgical teamThe surgical team recommends the patient to take over-the-counter medications | Other | Over the Counter Group |
Primary outcome
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.
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.
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.
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.
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.
8 secondary outcomes
Patient-reported consumption of opioid pills within 3 days after discharge from surgery
Time frame: 3 days following surgery discharge
Patient-reported consumption of opioid pills as reported at 12-16 days after discharge from surgery
Time frame: 12-16 days following surgery discharge
Pain intensity at site of surgery 3 days following surgery discharge
Time frame: 3 days following surgery discharge
Pain intensity at site of surgery as reported at 12-16 days following surgery discharge
Time frame: 3 days following surgery discharge
Medication side effects within 3 days following surgery discharge
Time frame: 3 days following surgery discharge
Patient satisfaction with pain treatment within 3 days following surgery discharge
Time frame: 3 days following surgery discharge
Patient use of magnesium within 3 days after discharge from surgery
Time frame: 3 days following surgery discharge
Delayed magnesium use days as reported at 12-16 days after discharge from surgery
Time frame: 12-16 days following surgery discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Bicket, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription by surgical team and Recommendation by surgical team in people with Acute Pain and Surgery, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal consumption of acetaminophen and NSAIDs within 3 days after discharge from surgery (time frame: 3 days following surgery discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.