NSAIDS Versus Opioids in Acute SER II Ankle Fractures

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373254
• Other study ID #: 656916
• Status: Completed
• Phase: Early Phase 1
• First received: February 9, 2015
• Last updated: July 11, 2017
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Drug:
• Ibuprofen
Ibuprofen 400 mg and 800 mg
• Acetaminophen/hydrocodone
Norco 5/325 mg and 10/325 mg

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fracture healing as measured by radiographic evaluation	fracture healing at 12 weeks followup	12 weeks
Secondary	pain level improvement as measured by VAS score	VAS score	1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks
Secondary	functional improvement as measured by AAOS score	AAOS scale	1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks