Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
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ClinicalTrials.gov Identifier: NCT02929589 |
Recruitment Status :
Terminated
(The use of robotic surgery made this study obsolete.)
First Posted : October 11, 2016
Last Update Posted : January 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Hernia | Drug: Ibuprofen Drug: Opioid Medication Drug: Placebo Drug: Ibuprofen + Opioid medication | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy: A Prospective, Placebo-Controlled, Double-Blind, Randomized Controlled Trial |
Actual Study Start Date : | July 5, 2018 |
Actual Primary Completion Date : | August 23, 2021 |
Actual Study Completion Date : | August 23, 2021 |

Arm | Intervention/treatment |
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Experimental: Opioid naïve patients-Group A
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. . |
Drug: Ibuprofen
ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days |
Experimental: Non-Opioid naïve patients-Group C
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.
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Drug: Ibuprofen + Opioid medication
ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 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 |
Placebo Comparator: Opioid naïve patients-Group B
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.
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Drug: Placebo
800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain |
Experimental: Non-Opioid naïve patients-Group D
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).
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Drug: Opioid Medication
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 |
- The primary outcome measure is morphine equivalent units to measure pain intensity difference and total pain relief. [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929589
United States, Nevada | |
Mike O'Callaghan Federal Medical Center | |
Nellis Air Force Base, Nevada, United States, 89191 |
Responsible Party: | Mike O'Callaghan Military Hospital |
ClinicalTrials.gov Identifier: | NCT02929589 |
Other Study ID Numbers: |
FWH20160095H |
First Posted: | October 11, 2016 Key Record Dates |
Last Update Posted: | January 28, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Ibuprofen Analgesics, Opioid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Narcotics Central Nervous System Depressants |