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Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy

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ClinicalTrials.gov Identifier: NCT02929589
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pain Hernia Drug: Ibuprofen Drug: Opioid Medication Drug: Placebo Drug: Ibuprofen + Opioid medication Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

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Arms and Interventions
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Arm Intervention/treatment
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.

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 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.
 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.
 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).
 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


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure is morphine equivalent units to measure pain intensity difference and total pain relief. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jill Clark 7026533298 jill.m.clark15.ctr@mail.mil

Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Principal Investigator: William Scott, DO         
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
More Information
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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02929589     History of Changes
Other Study ID Numbers: FWH20160095H
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Analgesics, Opioid
Oxycodone
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action