NSAIDS Versus Opioids in Acute SER II Ankle Fractures
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | January 2015 |
| End Date: | June 2017 |
| Contact: | Caren L Galloway |
| Email: | clgalloway@ucdavis.edu |
| Phone: | 916-734-6999 |
Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
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.
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.
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.
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.
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
We found this trial at
1
site
University of California-Davis As we begin our second century, UC Davis is poised to become...
Click here to add this to my saved trials
