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临床试验/NCT02373254
NCT02373254已完成早期 1 期

Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study

University of California, Davis1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
1
试验地点
1
主要终点
fracture healing as measured by radiographic evaluation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 to < 60
  • Isolated ankle fracture type SER II
  • Ability to speak and understand English

排除标准

  • 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
  • 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

研究组 & 干预措施

Ibuprofen 400 mg

Active Comparator

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.

干预措施: Ibuprofen (Drug)

Ibuprofen 800 mg

Active Comparator

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.

干预措施: Ibuprofen (Drug)

Norco

Active Comparator

Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.

干预措施: Acetaminophen/hydrocodone (Drug)

结局指标

主要结局

fracture healing as measured by radiographic evaluation

时间窗: 12 weeks

fracture healing at 12 weeks followup

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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