NSAIDs for Pain After Ankle Fracture Surgery

NCT02281968 | Withdrawn Phase 4 DMC

• 1 other identifier: 13-391A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Closed Fracture of Ankle

Outcome Measures

Primary Outcomes (2)

• Opioid consumption

  opioid equivalents

  twelve months

• Pain scores

  Visual analog scores

  twelve months

Secondary Outcomes (1)

• bone healing

  12 months

Study Arms (2)

NSAID cohort

EXPERIMENTAL

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

Placebo cohort

PLACEBO COMPARATOR

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

Interventions

Naproxen DRUG

Standing regimen of naproxen in experimental group to reduce need for narcotic to control pain

Also known as: Naproxen sodium, Naprosyn, Aleve, Anaprox

NSAID cohort

Placebo DRUG

Placebo cohort

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Sustained an operative ankle fracture that will be treated at Long Island Jewish Medical Center or North Shore University Hospital

You may not qualify if:

• Open fracture
• Pregnant women
• Nursing women
• Dementia
• Cognitive compromise requiring legal authorized representative Prisoners
• Uncontrolled hypertension
• History of peptic ulcer disease
• Renal insufficiency
• History of renal transplant
• eGFR less than 60 mL/min/1.73 m2
• Chronic liver disease
• Blood thinners: vitamin K antagonist, factor Xa inhibitors, heparinoids
• Chronic steroids
• Immunosuppressive drugs
• Inflammatory bowel disease

Sponsors & Collaborators

• Northwell Health: lead

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ariel T. Goldman, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 4, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12