Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Numbers of participants with nonunion (secondary surgery to promote union)
研究概览
简要总结
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
详细描述
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. Patients with diaphyseal tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management with no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
The hypothesis is that pain management using up to 6 weeks of NSAIDs will result in improved pain control and lower opioid consumption but demonstrate non-inferior levels of complications compared to standard of care pain management. The aim of the study is to:
Specific Aim: Evaluate the effect of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.
Primary Hypothesis: When compared to patients who received standard of care pain management, patients treated with up to 6 weeks of NSAIDs will have noninferior rates of surgery for to promote union at one year.
Secondary Hypotheses: When compared to patients who received standard of care pain management without NSAIDs, patients treated with up to 6 weeks of NSAIDs will benefit from (1) reduced opioid utilization; (2) reduced levels of persistent pain; (3) reduced pain interference; (4) improved functional outcomes; (5) noninferior rates of analgesic treatment related side effects; and (6) noninferior rates of radiographic union.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
- •Patients 18-80 years old inclusive.
- •Patients able to be followed at a Major Extremity Trauma & Rehabilitation (METRC) facility for at least 12 months following injury
排除标准
- •Patient unable to provide informed consent
- •Patients who are current - intravenous drug user.
- •Patients with a history of allergy to the study drugs.
- •Patients unable to swallow oral medications or without functioning GI tract.
- •Patients with a history of gastrointestinal bleeds or gastric perforation.
- •Patients with a history of stroke or heart attack.
- •Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
- •Patients with any bleeding disorders.
- •Patients with severe renal failure [glomerular filtration rate (GFR):<30]. Patients with moderate renal failure [GFR: 30-59] may participate in the study at a modified dose.
- •Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- •Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
- •Patients with a Glasgow Coma Scale (GCS) <15 at discharge.
- •Patients with a closed head injury that precludes NSAIDS.
- •Patients who are pregnant or lactating at time of screening
- •Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.
研究组 & 干预措施
NSAID
Standard of care pain medication regimen with NSAIDs.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Numbers of participants with nonunion (secondary surgery to promote union)
时间窗: Between 3 months and 12 months after definitive fixation surgery
Nonunion will be assessed by the presence of a secondary surgery to promote union after 3 months post definitive fixation surgery. Surgery operative notes and radiographs of each case will be independently reviewed by members of the METRC Central Adjudication Committee and if at least 2 members agree with the assessment of secondary surgery to promote union, no further review will be necessary. The METRC Central Adjudication Committee will convene to discuss the cases for which there is disagreement regarding nonunion assessment.
次要结局
- Pain as assessed by the Brief Pain Inventory (BPI)(Baseline, 3, 6, 12, months)
- Physical and Psychosocial functioning as assessed by Patient Report Outcomes Measurement Information System (PROMIS)(Baseline, 3, 6, 12, months)
- Pain interference as assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference(Baseline, 3, 6, 12, months)
- Radiographic union as assessed by the modified Radiographic Union Scale in Tibial Fractures (mRUST)(Between 3 months and 12 months after definitive fixation surgery)