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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: Clinical Trial Phase 3 study, sponsored by Mike O'Callaghan Military Hospital.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.
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 |
Why NCT02929589 stopped before completion
NCT02929589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02929589 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02929589's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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