Clinical trial NCT02373254: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ankle Fracture
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fracture healing as measured by radiographic evaluation
timeFrame: 12 weeks
Secondary outcomes:
measure: pain level improvement as measured by VAS score
timeFrame: 1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks
measure: functional improvement as measured by AAOS score
timeFrame: 1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Robert J Steffner, MD
role: PRINCIPAL_INVESTIGATOR
References: