Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
Pain, Hernia
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
PATIENTS MUST HAVE MILITARY INSURANCE TO PARTICIPATE
Inclusion/exclusion criteria:
Inclusion:
- Active Duty members and DoD beneficiary patient 18 years or older
- Elective, open unilateral inguinal herniorrhaphy using Lichtenstein (tension free with mesh) hernia repair technique Agree to take only the prescribed oral analgesic medication (oxycodone/acetaminophen), plus or minus ibuprofen, for the initial fourteen-day post-operative period, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued.Agree to honestly complete a depression screening questionnaire, illicit drug use personal history and questionnaire, and physical activity assessment questionnaire, with the knowledge that if the patient is an active duty member, this information could result in a referral to medical or command authorities for potential Uniform Code of Military Justice (UCMJ) violations or concerns for subject health and fitness for duty.
Exclusion:
- Subjects who are pregnant or nursing.
- Patients who refuse to complete the illicit drug use, physical activity, and depression questionnaires.
- Strangulated, incarcerated, or otherwise emergent, urgent, and non-elective inguinal herniorrhaphy.
- Those patients who are allergic to, refuse to take, or are otherwise unable to take oxycodone, ibuprofen, or acetaminophen medication orally for post-operative pain management.
- Patients on pain contracts, or under the care of a pain medicine specialist for management of chronic pain at the time of surgery.
- Subjects with serum creatinine level > 1.3 mg/dL as measured at the baseline study visit.
- Subjects with serum aspartate transaminase (AST) greater than 3 times the upper limit of normal (level >102 U/L)
- Subjects with serum alanine transaminase (ALT) greater than 3 times the upper limit of normal (level > 165 U/L)
- Subjects who do not speak, read, and write fluently in English.
- Subjects with a history of cirrhosis.
- Subjects enrolled in another clinical trial during the same period as their involvement as this study.
- Subjects, who in the investigator's opinion, will be unable to complete a pain diary or follow-up visits, or otherwise not comply with the study protocol.
Sites / Locations
- Mike O'Callaghan Federal Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Experimental
Opioid naïve patients-Group A
Non-Opioid naïve patients-Group C
Opioid naïve patients-Group B
Non-Opioid naïve patients-Group D
Group A: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days. .
Group C: Subjects will be prescribed ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days, in addition to their preferred opioid medication prescription.
Group B:Subjects will be prescribed 800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain and 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days.
Group D: Subjects will be prescribed or advised to continue to take only their preferred current oral opioid prescription (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, or transdermal fentanyl).