Closed Fracture of Ankle Clinical Trial
Official title:
An NSAID Pain Protocol Provides Adequate Pain Relief in Ankle Fractures Treated Operatively
The purpose of this study is to investigate if it is possible to decrease opioid consumption in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo controlled study with two groups of patients: one getting NSAIDs to take at regularly scheduled times plus a traditional prescription for opioid medication and one receiving the traditional prescription for opioid medication and a placebo. Patients will be assigned to a group from a computer-generated program. Neither the patients nor their doctors or nurses will know what group they are in, only the pharmacist will have that information. Patients in both groups will have the opportunity to take opioid medications if the pain becomes unmanageable.
Rationale: Opioid abuse is rampant, can have bad consequences, and is a source of many
individual and societal problems. Although its use fulfills a role in pain control, this
investigation seeks to find a pain control alternative with the potential for fewer adverse
consequences for patient undergoing surgery for ankle fracture.
Hypothesis: A structured regimen of NSAIDs (drugs such as ibuprofen or naproxen) during and
after ankle fracture surgery will provide adequate pain relief and cause patients to take
fewer doses of opioid drugs.
Methods: This will be a prospective, randomized, double-blinded, placebo controlled study of
patients with ankle fractures who require surgical treatment by several NSLIJ orthopaedic
surgeons at North Shore University Hospital and Long Island Jewish Medical Center. There
will be two groups of patients: one getting NSAIDs to take at regularly scheduled times plus
a traditional prescription for opioid medication and one receiving the traditional
prescription for opioid medication and a placebo. Patients will be assigned to a group from
a computer-generated program. Neither the patients nor their doctors or nurses will know
what group they are in, only the pharmacist will have that information. Patients in both
groups will have the opportunity to take opioid medications if the pain becomes
unmanageable. We are evaluating whether patients in the NSAIDs group will a) have no more
pain than patients who are prescribed opioid pain killers for the same surgery and b) if the
amount of opioid pain killers can be reduced by having patients take scheduled doses of
NSAIDs. We will also describe how well or poorly patients heal, looking at several
timepoints after surgery, using Xrays to evaluate formation of new bone.
The test (experimental) group will be given a dose of IV (intravenous) ketorolac, which is
an NSAID, during surgery, and will be given naproxen 500mg orally two times per day to take
on a regular basis after surgery for four weeks. This group will be given percocet 5/325 (an
opioid medication) 1-2 pills orally every 4 hours to take as pain medication if the naproxen
is not providing adequate pain relief.
The control group will be administered a saline dose during surgery as an equivalent to the
IV ketorolac. These patients will take placebo pain pills on a regular basis two times per
day for four weeks, and will take percocet for pain relief. This is equivalent to the common
pain protocol that is given to patients after ankle fracture surgery, where they are given
percocet to be taken on an as-needed basis.
The placebo and naproxen medication will be in unidentifiable capsule form in unmarked
bottles. The maximum daily dose of percocet will be 8 pills, so as not to exceed 2.6g
acetaminophen daily.
Both groups will take aspirin (ASA) 325mg orally daily for two weeks to prevent blood clots.
All patients will take pantoprazole 40mg orally once daily. Pantoprazole is a proton pump
inhibitor (PPI) that suppresses the production of stomach acid, to prevent the development
of gastrointestinal ulcers.
We will collect demographic data about the patients. We will also collect data about the
surgery: surgery time, treating surgeon, type of surgery, location and complexity of
fracture.
W are studying the following outcomes: pain relief, opioid use and bone healing. To measure
these outcomes, we will use a pain scale called the VAS to look for differences between the
group. A change of 10 millimeters on a scale of 100 millimeters will considered to be the
important pain difference. We will also ask patients to fill out journals of their
medication use, we will perform pill counts, examine Xrays and ask patients to respond to
the FFI, a questionnaire to evaluate how well they are functioning.
Patients will be seen for followup at 2 weeks, 6 weeks, 2 months, 6 months, and 1 year after
surgery, all but the last visit are the usual and standard visits scheduled after ankle
fracture surgery. At each visit, Xrays will be taken of the ankle to evaluate ankle
position, and to determine whether bone healing has occurred. Patients will not incur any
extra expense as a result of participating in the study.
Since patients will not know which group they have been assigned to -- test (experimental)
or control -- the investigators will carefully explain how to determine the need for taking
the prescribed opioid pain medication such that patients are not subjected to unnecessary
pain. Since both groups will have access to opioid pain medications, the study is designed
to determine if those patients in the NSAIDs group already getting the relief from pain will
experience pain at lower levels, which we will only be able to determine after the study is
completed and the blind is broken.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care