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NCT02929589 · ClinicalTrials.gov registry record · Phase 3
Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
A Phase 3 study, sponsored by Mike O'Callaghan Military Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT02929589 is a Phase 3 study that was terminated before completion, run by Mike O'Callaghan Military Hospital. The registered enrollment target is 18 participants.
The verdict
NCT02929589, a Phase 3 study, was terminated before completion, sponsored by Mike O'Callaghan Military Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
Interventions
- DRUG Placebo
- DRUG Ibuprofen
- DRUG Opioid Medication
- DRUG Ibuprofen + Opioid medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2021-08-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02929589
The ClinicalTrials.gov registry entry for NCT02929589 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mike O'Callaghan Military Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02929589 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02929589 about?
NCT02929589 is a clinical study titled "Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy". This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, h...
What is the current status of trial NCT02929589?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2018-07-05. Estimated completion is 2021-08-23.
What interventions are being tested in trial NCT02929589?
The interventions under investigation include: Placebo (DRUG), Ibuprofen (DRUG), Opioid Medication (DRUG), Ibuprofen + Opioid medication (DRUG).
Who is sponsoring clinical trial NCT02929589?
This trial is sponsored by Mike O'Callaghan Military Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
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