Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02929589 |
| Other study ID # |
FWH20160095H |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2018 |
| Est. completion date |
August 23, 2021 |
Study information
| Verified date |
March 2024 |
| Source |
Mike O'Callaghan Military Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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, 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.
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)
