PainPhase 3NCT02929589
Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
A Phase 3 study testing Ibuprofen, Opioid Medication and Ibuprofen + Opioid medication in people with Pain and Hernia, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ibuprofen, Opioid Medication and Ibuprofen + Opioid medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 23 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy: A Prospective, Placebo-Controlled, Double-Blind, Randomized Controlled Trial
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.
Read the detailed description
Screening Visit:
Discuss the purpose of the study and the required completion of study-related questionnaires and their potential impact for active duty members. (research-driven) Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
Review the patient's past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria. (research-driven) The investigators will record the subject's tobacco use history, alcohol use history, marijuana use history, other illicit drug use history, and previous non-prescription use of opioids. (standard of care) Obtain an overall pain score, from 0 to 100, with 100 being the worst pain imaginable. (research-driven) Obtain a localized pain score from 0 to 100, with 100 being the worst pain imaginable, which the patient attributes specifically to the hernia that is scheduled for surgical intervention. (research-driven) Instruct patients to discontinue use of any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study.
Subjects will have the following blood test drawn, which include (research-driven):
Fasting comprehensive metabolic panel (liver function, renal function, plasma glucose tests) via 1 venipuncture (5-10 milliliters, approximately 1-2 teaspoons of blood will be drawn) Subject's CMP results must be within 30 days of the day of surgery or it will need to be repeated.
Women of childbearing potential will have a serum pregnancy test (5-10 milliliters, approximately 1-2 teaspoons of blood) or urine pregnancy test (10 drops or less than 1 milliliter of urine) (research-driven). Visit 1 (may occur the same day as the screening visit or the same day as visit 2):
The standard of care local anesthesia used for this type of surgery is bupivacaine. The surgeon will be reminded via a note in the medical record. (standard of care) Subjects will be randomized by the MOFMC Pharmacy into one of two naturally stratified groups (e.g., opioid naive patients and non-opioid naive patients), with further randomization into an opioid + ibuprofen study group or an opioid + placebo study group The MOFMC Pharmacy staff will maintain a key that can be used to un-blind the randomization scheme if needed for an emergent patient care issue. Study ID numbers will be used to maintain blinding and confidentiality. (research-driven)
Opioid naive patients (used an opioid for less than 14 days in the past 6 months, and no history of opioid use disorder at any time) will be randomized into one of two groups:
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 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.
Non-Opioid naive patients (opioid use for more than 14 days in the past 6 months, or history of opioid use disorder) will be randomized into one of two groups:
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 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).
Subjects will complete the Beck Depression Inventory-II or the Patient Health Questionnaire (PHQ-9) depression screen, and it will be reviewed on the same day of completion. (research-driven) Subjects will complete the Pre-Operative Activities Assessment Scale (AAS), and it will be reviewed on the same day of completion. (research-driven) Subjects will complete the Opioid Risk Tool (ORT) , and it will be reviewed on the same day of completion. (research-driven) Subjects will be asked "How likely do you think it is that you will develop an addiction problem from pain medication you take after surgery?" and chose from 1 of 4 answers: 1: "not at all"; 2: "unlikely"; 3: "somewhat likely"; or 4: "very likely". (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is your average level of pain at rest in the past 24 hours?" (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your lowest level of pain when at rest in the past 24 hours? (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your highest level of pain when at rest in the past 24 hours? (research-driven) Subjects will be given a Medication and Pain Level Diary and will be instructed to complete it every day for 14 days beginning after their surgery. The investigators will record information from the subjects' surgery, for example: the start and end times of surgery and anesthesia, how long the surgery lasted, how difficult the surgery was, were the ilioinguinal, genitofemoral, or iliohypogastric nerves identified and were they protected, injured, or transected, and which opioids the anesthesiologist gives at any point during the case after incision. (research-driven) The preoperative instructions will include standardized verbal and written instructions: "After your surgery, it is expected that the patient will experience a certain amount of pain for a short period of time. The patient will be prescribed pain medication that you should take only when you are in pain. If the patient is no longer experiencing pain, the patient should stop taking the medication. If the patient does not require all of the pain medication that was prescribed, the patient should record the amount of medication that was unused and then properly dispose of the remainder." (standard of care)
Visit 2 (day of surgery-prior to surgery):
Subjects will receive prescriptions for medications according to their randomization group. These prescriptions will be filled at the MOFMC pharmacy, which will perform the subjects' randomization assignments. The ibuprofen and placebo capsules will be delivered to the MOFMC Pharmacy after being compounded by Solutions Specialty Pharmacy. (research-driven) Subjects will complete the Pre-Operative AAS (approximately 5 minutes to complete), and it will be reviewed on the same day of completion. (research-driven) Research staff will record the start and end times of the surgery, record the amounts of standard of care pain medications used during their hospital stay, document any standard of care pain assessments that were performed, and document the anesthesia the subject received. (research-driven) Subjects will be reminded in the Post Anesthesia Care Unit (PACU) to complete their Medication and Pain Level Diary and reminded to complete it every day for the 60 days beginning after they are discharged from the hospital. (research-driven)
Visit 3 (Post-Op day 0 Contact (at time of discharge from post-anesthesia care unit)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are the patient taking including the strength (in milligrams), and how many total doses have you taken since your surgery? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visits 4-8 (Post-op Day 1 through Day 5 Contact (each visit every 24 hours plus or minus 4 hours visit window):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain since when at rest in the past 24 hours? What pain medications have been taken, including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven) Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visit 9 (Post-Op day 14 Contact (plus or minus 2 day visit window)):
Subjects will be contacted by research team in person or via telephone at their Post-Operative Follow Up Visit and asked the following questions in this order (in-person) (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your lowest level of pain since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your highest level of pain since your when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
Subjects will return their Medication and Pain Level Diary and be issued a new one for the remainder of the study. (research-driven) Subjects will be reminded of the two remaining contacts. (research-driven)
Visit 10 (Post-Op day 30 Contact (plus or minus 5 day visit window)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since your last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visit 11 (Post-Op day 60 Contact (plus or minus 5 day visit window)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is your average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Was there a diagnosis of post-operative neuralgia at any point following your surgery? Was there a diagnosis of an inguinal hernia recurrence at any point following your surgery? Was there a diagnosis of a surgical site infection at any point following your surgery? Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
The Medication and Pain Level Diary will not be collected from the patient. (research-driven)
- Being tested
- Ibuprofen, Opioid Medication, Placebo, Ibuprofen + Opioid medication
- Medical subject headings
- Pain, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days
Opioid MedicationDrug
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
PlaceboDrug
800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain
Ibuprofen + Opioid medicationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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.
. Receives: 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. Receives: 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. Receives: 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). Receives: Drug: Opioid Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Milligram Morphine Equivalent (MME) Units
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.
Measured: 60 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start5 Jul 2018
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
Why it stopped: The use of robotic surgery made this study obsolete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929589
- Sponsor's protocol ID
- FWH20160095H
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2016
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy: A Prospective, Placebo-Controlled, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02929589
- Acronym / sponsor ID
- FWH20160095H
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The use of robotic surgery made this study obsolete.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening Visit:
Discuss the purpose of the study and the required completion of study-related questionnaires and their potential impact for active duty members. (research-driven) Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
Review the patient's past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria. (research-driven) The investigators will record the subject's tobacco use history, alcohol use history, marijuana use history, other illicit drug use history, and previous non-prescription use of opioids. (standard of care) Obtain an overall pain score, from 0 to 100, with 100 being the worst pain imaginable. (research-driven) Obtain a localized pain score from 0 to 100, with 100 being the worst pain imaginable, which the patient attributes specifically to the hernia that is scheduled for surgical intervention. (research-driven) Instruct patients to discontinue use of any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study.
Subjects will have the following blood test drawn, which include (research-driven):
Fasting comprehensive metabolic panel (liver function, renal function, plasma glucose tests) via 1 venipuncture (5-10 milliliters, approximately 1-2 teaspoons of blood will be drawn) Subject's CMP results must be within 30 days of the day of surgery or it will need to be repeated.
Women of childbearing potential will have a serum pregnancy test (5-10 milliliters, approximately 1-2 teaspoons of blood) or urine pregnancy test (10 drops or less than 1 milliliter of urine) (research-driven). Visit 1 (may occur the same day as the screening visit or the same day as visit 2):
The standard of care local anesthesia used for this type of surgery is bupivacaine. The surgeon will be reminded via a note in the medical record. (standard of care) Subjects will be randomized by the MOFMC Pharmacy into one of two naturally stratified groups (e.g., opioid naive patients and non-opioid naive patients), with further randomization into an opioid + ibuprofen study group or an opioid + placebo study group The MOFMC Pharmacy staff will maintain a key that can be used to un-blind the randomization scheme if needed for an emergent patient care issue. Study ID numbers will be used to maintain blinding and confidentiality. (research-driven)
Opioid naive patients (used an opioid for less than 14 days in the past 6 months, and no history of opioid use disorder at any time) will be randomized into one of two groups:
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 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.
Non-Opioid naive patients (opioid use for more than 14 days in the past 6 months, or history of opioid use disorder) will be randomized into one of two groups:
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 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).
Subjects will complete the Beck Depression Inventory-II or the Patient Health Questionnaire (PHQ-9) depression screen, and it will be reviewed on the same day of completion. (research-driven) Subjects will complete the Pre-Operative Activities Assessment Scale (AAS), and it will be reviewed on the same day of completion. (research-driven) Subjects will complete the Opioid Risk Tool (ORT) , and it will be reviewed on the same day of completion. (research-driven) Subjects will be asked "How likely do you think it is that you will develop an addiction problem from pain medication you take after surgery?" and chose from 1 of 4 answers: 1: "not at all"; 2: "unlikely"; 3: "somewhat likely"; or 4: "very likely". (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is your average level of pain at rest in the past 24 hours?" (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your lowest level of pain when at rest in the past 24 hours? (research-driven) Subjects will be asked "On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your highest level of pain when at rest in the past 24 hours? (research-driven) Subjects will be given a Medication and Pain Level Diary and will be instructed to complete it every day for 14 days beginning after their surgery. The investigators will record information from the subjects' surgery, for example: the start and end times of surgery and anesthesia, how long the surgery lasted, how difficult the surgery was, were the ilioinguinal, genitofemoral, or iliohypogastric nerves identified and were they protected, injured, or transected, and which opioids the anesthesiologist gives at any point during the case after incision. (research-driven) The preoperative instructions will include standardized verbal and written instructions: "After your surgery, it is expected that the patient will experience a certain amount of pain for a short period of time. The patient will be prescribed pain medication that you should take only when you are in pain. If the patient is no longer experiencing pain, the patient should stop taking the medication. If the patient does not require all of the pain medication that was prescribed, the patient should record the amount of medication that was unused and then properly dispose of the remainder." (standard of care)
Visit 2 (day of surgery-prior to surgery):
Subjects will receive prescriptions for medications according to their randomization group. These prescriptions will be filled at the MOFMC pharmacy, which will perform the subjects' randomization assignments. The ibuprofen and placebo capsules will be delivered to the MOFMC Pharmacy after being compounded by Solutions Specialty Pharmacy. (research-driven) Subjects will complete the Pre-Operative AAS (approximately 5 minutes to complete), and it will be reviewed on the same day of completion. (research-driven) Research staff will record the start and end times of the surgery, record the amounts of standard of care pain medications used during their hospital stay, document any standard of care pain assessments that were performed, and document the anesthesia the subject received. (research-driven) Subjects will be reminded in the Post Anesthesia Care Unit (PACU) to complete their Medication and Pain Level Diary and reminded to complete it every day for the 60 days beginning after they are discharged from the hospital. (research-driven)
Visit 3 (Post-Op day 0 Contact (at time of discharge from post-anesthesia care unit)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are the patient taking including the strength (in milligrams), and how many total doses have you taken since your surgery? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visits 4-8 (Post-op Day 1 through Day 5 Contact (each visit every 24 hours plus or minus 4 hours visit window):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain since when at rest in the past 24 hours? What pain medications have been taken, including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven) Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visit 9 (Post-Op day 14 Contact (plus or minus 2 day visit window)):
Subjects will be contacted by research team in person or via telephone at their Post-Operative Follow Up Visit and asked the following questions in this order (in-person) (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your lowest level of pain since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was your highest level of pain since your when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
Subjects will return their Medication and Pain Level Diary and be issued a new one for the remainder of the study. (research-driven) Subjects will be reminded of the two remaining contacts. (research-driven)
Visit 10 (Post-Op day 30 Contact (plus or minus 5 day visit window)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is the average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since your last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
Subjects will be reminded to complete their Medication and Pain Level Diary. (research-driven)
Visit 11 (Post-Op day 60 Contact (plus or minus 5 day visit window)):
Subjects will be contacted by research team in person or via telephone and asked the following questions in this order (research-driven):
On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what is your average level of pain when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the lowest level of pain since your when at rest in the past 24 hours? On a scale of 0-100, with 0 being no pain and 100 being the worst pain imaginable, what was the highest level of pain when at rest in the past 24 hours? What pain medications are being taken including the strength (in milligrams), and how many total doses have been taken since the last study visit? Time of last opioid medication taken? Relief from starting pain is: 0 = none, 1= a little, 2 = some, 3 = a lot, 4 = complete Was there a diagnosis of post-operative neuralgia at any point following your surgery? Was there a diagnosis of an inguinal hernia recurrence at any point following your surgery? Was there a diagnosis of a surgical site infection at any point following your surgery? Subjects will complete the Post-Operative AAS, and it will be reviewed on the same day of completion. (research-driven).
The Medication and Pain Level Diary will not be collected from the patient. (research-driven)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Opioid naïve patients-Group A | Experimental | Drug: IbuprofenGroup 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. . |
| Non-Opioid naïve patients-Group C | Experimental | Drug: Ibuprofen + Opioid medicationGroup 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. |
| Opioid naïve patients-Group B | Placebo comparator | Drug: PlaceboGroup 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. |
| Non-Opioid naïve patients-Group D | Experimental | Drug: Opioid MedicationGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofenibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days | Drug | Opioid naïve patients-Group A |
| Opioid Medication1 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 | Non-Opioid naïve patients-Group D |
| Placebo800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain | Drug | Opioid naïve patients-Group B |
| Ibuprofen + Opioid medicationibuprofen 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 | Drug | Non-Opioid naïve patients-Group C |
Primary outcome
Total Milligram Morphine Equivalent (MME) Units
Time frame: 60 days post-operation
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen, Opioid Medication and Ibuprofen + Opioid medication in people with Pain and Hernia, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Milligram Morphine Equivalent (MME) Units (time frame: 60 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.