Ankle Fracture Clinical Trial
Official title:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01484535 -
Aspiration for Pain Relief Following Ankle Fracture
|
N/A | |
Completed |
NCT02779244 -
Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
|
N/A | |
Completed |
NCT01561365 -
Applicability of the Ottawa Ankle Rules
|
N/A | |
Completed |
NCT02609347 -
Manual Therapy After Ankle/Hindfoot Fractures
|
N/A | |
Withdrawn |
NCT02863042 -
Is Deltoid Ligament Repair for Ankle Fracture Necessary?
|
N/A | |
Completed |
NCT01444144 -
Ankle Fracture Treatment in the Elderly
|
N/A | |
Completed |
NCT01729195 -
Ankle Syndesmosis Fixation by Antibiotic Releasing Bioabsorbable Screw
|
Phase 2 | |
Completed |
NCT01341015 -
Bedside Ultrasound in the Diagnosis of Ankle Fractures in Children
|
Phase 0 | |
Completed |
NCT01431560 -
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
|
Phase 4 | |
Unknown status |
NCT01654393 -
Triage Nurse Initiated Radiographs According to OAR
|
N/A | |
Completed |
NCT00132964 -
Brace Versus Casting in Pediatric Low Risk Ankle Fractures
|
N/A | |
Recruiting |
NCT02029170 -
Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture
|
N/A | |
Completed |
NCT02072135 -
Exparel and Ankle Surgery
|
N/A | |
Completed |
NCT01126398 -
Trauma Expectation Factor Trauma Outcome Measure
|
||
Completed |
NCT02480621 -
Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)
|
Phase 3 | |
Completed |
NCT01493167 -
Study on Wood-plastic Composite for Circumferential Casting
|
N/A | |
Completed |
NCT02334618 -
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
|
N/A | |
Active, not recruiting |
NCT02032966 -
Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT01338129 -
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
|
N/A |