A Phase 4 interventional study of Naproxen and Placebo in Closed Fracture of Ankle, sponsored by Northwell Health. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-18.
Sponsored by Northwell Health · Phase 4, Interventional, and Supportive care
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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HIV
The human immunodeficiency virus, which weakens the immune system.
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Patients who have had surgical management of ankle fracture will be given a standing regimen (scheduled doses) of 500 mg naproxen twice a day and will have received one intraoperative dose of ketorolac. Patients will have a prescription for opioids for breakthrough pain.
Drug: Naproxen
Patients who have had surgical management of ankle fracture will be given a standing regimen (scheduled doses) of placebo twice a day and will have received one intraoperative dose of saline solution. Patients will have a prescription for opioids for pain.
Drug: Placebo
Standing regimen of naproxen in experimental group to reduce need for narcotic to control pain
Also known as: Naproxen sodium, Naprosyn, Aleve, Anaprox
Opioid consumption
opioid equivalents
Time frame: twelve months
Pain scores
Visual analog scores
Time frame: twelve months
bone healing
At each scheduled timepoint from visits 1 through 5, Xrays will be taken of the ankle to evaluate ankle position, and to determine presence and degree of bridging callus on four cortices to evaluate bone healing as a precursor to bony union.
Time frame: 12 months
No study locations are listed for this record.
The record gives a start of Dec 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naproxen