NSAIDS Versus Opioids in Acute SER II Ankle Fractures
Primary Purpose
Ankle Fracture
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen/hydrocodone
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fracture
Eligibility Criteria
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
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ibuprofen 400 mg
Ibuprofen 800 mg
Norco
Arm Description
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.
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.
Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
Outcomes
Primary Outcome Measures
fracture healing as measured by radiographic evaluation
fracture healing at 12 weeks followup
Secondary Outcome Measures
pain level improvement as measured by VAS score
VAS score
functional improvement as measured by AAOS score
AAOS scale
Full Information
NCT ID
NCT02373254
First Posted
February 9, 2015
Last Updated
July 11, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02373254
Brief Title
NSAIDS Versus Opioids in Acute SER II Ankle Fractures
Official Title
Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen 400 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ibuprofen 800 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Norco
Arm Type
Active Comparator
Arm Description
Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin
Intervention Description
Ibuprofen 400 mg and 800 mg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/hydrocodone
Other Intervention Name(s)
Norco
Intervention Description
Norco 5/325 mg and 10/325 mg
Primary Outcome Measure Information:
Title
fracture healing as measured by radiographic evaluation
Description
fracture healing at 12 weeks followup
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
pain level improvement as measured by VAS score
Description
VAS score
Time Frame
1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks
Title
functional improvement as measured by AAOS score
Description
AAOS scale
Time Frame
1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Steffner, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NSAIDS Versus Opioids in Acute SER II Ankle Fractures
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