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

NCT02929589 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: FWH20160095H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Hernia

Outcome Measures

Primary Outcomes (1)

• Total Milligram Morphine Equivalent (MME) Units

  The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.

  60 days post-operation

Study Arms (4)

Opioid naïve patients-Group A

EXPERIMENTAL

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

Non-Opioid naïve patients-Group C

EXPERIMENTAL

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

Opioid naïve patients-Group B

PLACEBO COMPARATOR

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

Non-Opioid naïve patients-Group D

EXPERIMENTAL

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

Interventions

Ibuprofen DRUG

ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days

Opioid naïve patients-Group A

Opioid Medication DRUG

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

Non-Opioid naïve patients-Group D

Placebo DRUG

800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain

Opioid naïve patients-Group B

Ibuprofen + Opioid medication DRUG

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

Non-Opioid naïve patients-Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Pain; Hernia

Interventions

Ibuprofen; Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Drug Therapy; Therapeutics

Limitations and Caveats

This study was terminated early as the advent of the use of robotic surgery made this study obsolete.

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMMC

amanda.j.crawford.ctr@health.mil

702-653-3583

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 11, 2016
• Study Start: July 5, 2018
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)