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NSAIDS Versus Opioids in Acute SER II Ankle Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02373254
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This study is being conducted to evaluate whether NSAIDS are more or less effective in bone healing than opioids in acute fracture pain. Participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

Condition or disease Intervention/treatment Phase
Ankle Fracture Drug: Ibuprofen Drug: Acetaminophen/hydrocodone Early Phase 1

Detailed Description:

Pain management in acute fractures is challenging and influenced by several factors contributing to pain perception. These factors include but are not limited to tissue damage by the local impact, mechanical stress at the fracture ends, and central perception of the noxious stimulus. Tissue damage and mechanical stress leads to inflammation and further to local swelling. Swelling itself is significant contributor in pain development.

Ideal pain management would attack pain development at most sites possible. The current clinical practice in the US applies a derivate of an opioid analgesic combined with acetaminophen, thereby influencing pain development at central perception by the opioid analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. The exact mechanism of the peripheral effect is not known.

This clinical practice disregards the positive effect of medications influencing the peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs affect pain development by blocking the synthesis of arachidonic acid metabolites, inhibiting peripheral inflammatory response and central pain perception. The major reason for not applying NSAIDs in the treatment of acute fracture pain is an experimental animal study showing decreased bone healing in relation to NSAID usage.

However, clinical data thus far is inconclusive, whether bone healing is affected in humans and whether NSAIDs should be avoided in the setting of bone fractures.

This proposed study will give an answer whether the usage of NSAIDs in acute fractures has a negative effect on bone healing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
Actual Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ibuprofen 400 mg
Ibuprofen 400 mg po q 8 hours as needed (PRN) for pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient.
Drug: Ibuprofen
Ibuprofen 400 mg and 800 mg
Other Name: Motrin

Active Comparator: Ibuprofen 800 mg
Ibuprofen 800 mg po q 8 hours PRN pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient.
Drug: Ibuprofen
Ibuprofen 400 mg and 800 mg
Other Name: Motrin

Active Comparator: Norco
Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
Drug: Acetaminophen/hydrocodone
Norco 5/325 mg and 10/325 mg
Other Name: Norco

Primary Outcome Measures :
  1. fracture healing as measured by radiographic evaluation [ Time Frame: 12 weeks ]
    fracture healing at 12 weeks followup

Secondary Outcome Measures :
  1. pain level improvement as measured by VAS score [ Time Frame: 1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks ]
    VAS score

  2. functional improvement as measured by AAOS score [ Time Frame: 1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks ]
    AAOS scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 to < 60
  • Isolated ankle fracture type SER II
  • Ability to speak and understand English
  • BMI< 35

Exclusion Criteria:

  • ASA>3
  • Previous or acute gastric bleeding
  • Renal insufficiency (Creatinine: >1.27mg/dl)
  • Liver insufficiency (Child-Pugh-Wert: 10-15)
  • Malignant tumor
  • Rheumatoid arthritis
  • Heart failure (NYHA III-IV)
  • High frequency absolute arrhythmia
  • Patients with known psychiatric illness
  • Coagulopathy
  • Asthma
  • Function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria
  • Adults unable to consent
  • Pregnant women
  • Prisoners
  • Workers Comp patient
  • Early fracture displacement (within first 2 weeks) indicating need for surgery
  • Polytrauma
  • Concurrent participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02373254

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United States, California
University of California Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Robert J Steffner, MD University of California, Davis
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Responsible Party: University of California, Davis Identifier: NCT02373254    
Other Study ID Numbers: 656916
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents