Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
Status:
Suspended
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Mike O'Callaghan Federal Hospital Mike O'Callaghan Military Hospital
Treatments:
Acetaminophen, hydrocodone drug combination Analgesics, Opioid Ibuprofen