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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

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date July 14, 2017
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
fracture healing as measured by radiographic evaluation [ Time Frame: 12 weeks ]
fracture healing at 12 weeks followup
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • pain level improvement as measured by VAS score [ Time Frame: 1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks ]
    VAS score
  • functional improvement as measured by AAOS score [ Time Frame: 1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks ]
    AAOS scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE NSAIDS Versus Opioids in Acute SER II Ankle Fractures
Official Title  ICMJE Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankle Fracture
Intervention  ICMJE
  • Drug: Ibuprofen
    Ibuprofen 400 mg and 800 mg
    Other Name: Motrin
  • Drug: Acetaminophen/hydrocodone
    Norco 5/325 mg and 10/325 mg
    Other Name: Norco
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ibuprofen
  • 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.
    Intervention: Drug: Ibuprofen
  • Active Comparator: Norco
    Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
    Intervention: Drug: Acetaminophen/hydrocodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02373254
Other Study ID Numbers  ICMJE 656916
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Steffner, MD University of California, Davis
PRS Account University of California, Davis
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP