Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
Overview
- Phase
- Early Phase 1
- Intervention
- Ibuprofen
- Conditions
- Ankle Fracture
- Sponsor
- University of California, Davis
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- fracture healing as measured by radiographic evaluation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 to \< 60
- •Isolated ankle fracture type SER II
- •Ability to speak and understand English
Exclusion Criteria
- •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
- •Function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria
Arms & Interventions
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: Ibuprofen
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: Ibuprofen
Norco
Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
Intervention: Acetaminophen/hydrocodone
Outcomes
Primary Outcomes
fracture healing as measured by radiographic evaluation
Time Frame: 12 weeks
fracture healing at 12 weeks followup
Secondary Outcomes
- functional improvement as measured by AAOS score(1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks)
- pain level improvement as measured by VAS score(1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks)