Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 17
- 主要终点
- Opioid Utilization
研究概览
简要总结
The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial.
Also, as a significant proportion of this population develops chronic post traumatic osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence of chronic pain and PTOA in this population.
详细描述
In this study, will test whether adjunctive analgesic therapy during the pre and peri-operative period, in addition to standard of care pain management, can improve overall pain control and pain related outcomes without increasing analgesic related side effects.
Patients will be randomized into three treatment groups. The intervention will begin within 48 hours of admission and continue for up to the time of definitive fixation.
Group 1: standard pain management, plus intravenous and oral placebo for up to 48 hours following definitive fixation.
Group 2: standard pain management, plus intravenous NSAIDs (ketorolac) and oral placebo for up to 48 hours following definitive fixation.
Group 3: standard pain management, plus intravenous placebo and oral pregabalin for up to 48 hours following definitive fixation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients with one of the following types of injuries:
- •Unilateral, Grade I &II open or closed pilon (distal tibial plafond), calcaneus, talus fractures and Lisfranc dislocations requiring operative treatment with fixation; or
- •Unilateral, open (type I, II, or IIIA) ankle fractures with associated dislocation on presentation (OTA 44B3 or 44C) requiring operative treatment with fixation; or
- •Unilateral, open or closed distal and proximal humerus (OTA 11A-C and OTA 13 A-C); or
- •Open femoral shaft fracture (OTA 32 A-C; Gustilo Type I-IIIC) or open or closed supracondylar femur fractures (OTA 33 A-C); or
- •Open or closed tibial plateau or shaft fractures (OTA 42 A-C or 43 A-C)
- •Any combination of the above injuries which are surgically treated as a whole
- •Patients who present to the admitting hospital acutely or clinic following an initial assessment in the Emergency Department, for care up to 10 days following initial injury.
- •Patients 18-80 years old inclusive.
- •Patients who are English or Spanish competent.
- •Treating physicians agree that none of the study drugs are indicated for standard of care treatment for this patient.
- •Patients able to be followed at the METRC facility for at least 12 months following injury.
排除标准
- •Patients unable to provide informed consent.
- •Patients with chronic pain being presently treated with opioid or gabapentinoid prescription or any other alternative therapy.
- •Patients who are current IVDA
- •Patients with bilateral or ipsilateral injuries requiring surgery
- •Patients with other orthopedic or non-orthopedic injuries requiring operative intervention
- •Patients with severe osteopenia.
- •Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure).
- •Patients who are expected to have a post-surgical stay less than 24 hours.
- •Patients with a history of allergy to any drugs in the study.
- •Patients unable to swallow oral medications or without adequately functioning GI tract.
- •Patients with a history of gastrointestinal bleeds or gastric perforation.
- •Patients with a history of stroke or heart attack.
- •Patients currently receiving an aspirin or NSAID regimen (exception: low dose (81 mg) aspirin. See section 6.5) Patients with any bleeding disorders.
- •Patients with severe renal failure. Patients with moderate renal failure may participate in the study at a modified dose. See Section 9.
- •Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- •Patients using angiotensin-converting enzyme (ACE) inhibitors, who may be at increased risk of developing angioedema with pregabalin.
- •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 who experienced a loss of consciousness consistent with a clinical diagnosis of a closed head injury, or concern of a cerebrovascular bleed secondary to traumatic brain injury.
- •Patients with a GCS <15
- •Patient speaks neither English nor Spanish.
- •Patients who are pregnant or lactating at time of screening
研究组 & 干预措施
Placebo
Standard pain management + perioperative intravenous placebo & oral placebo.
Control group will receive an oral dose of placebo up to two hours prior to surgery and twice daily for up to 48 hours following any surgery, in addition to an intravenous dose of placebo up to two hours prior to surgery and every 6 hours for up to 48 hours following surgery. All study medications will be in addition to standard of care pain medication.
*Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.
干预措施: placebo (Drug)
NSAID
Standard pain management + perioperative intravenous ketorolac & oral placebo.
The NSAID group will receive 30 mg of intravenous (IV) ketorolac (Ketorolac 30 mg/ml dose vial, NDC 00409-3795-01; manufacturer: Hospira) administered up to two hours prior to the procedure and every 6 hours for up to 48 hours following the procedure. In addition, as part of the perioperative protocol, patients will receive an oral dose of placebo up to two hours prior to the procedure and every 12 hours for up to 48 hours following the procedure.
*Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.
干预措施: NSAID (Drug)
Gabapentinoid
Standard pain management + perioperative intravenous placebo & oral pregabalin.
The Pregabalin group will receive an oral bolus dose of 300 mg of pregabalin up to two hours prior to the procedure and a 75 mg dose every 12 hours for up to 48 hours following the procedure. In addition, as part of the perioperative protocol, patients will receive an IV dose of placebo up to two hours prior to the procedure and every 6 hours for up to 48 hours following the procedure.
*Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.
干预措施: Gabapentinoids (Drug)
结局指标
主要结局
Opioid Utilization
时间窗: 1 year
Morphine equivalent opioid utilization during initial hospitalization through 48 hours following definitive fixation.
Persistent Pain
时间窗: 1 year
Patient reported persistent pain states at standard of care visits 3, 6 and 12 months following hospital discharge. Measured using the Brief Pain Inventory (BPI) and an additional battery of questions to assess neuropathic pain (painDETECT).
Surgery for non-union
时间窗: 1 year
Defined as non-prophylactic surgery for nonunion performed between six months and a year following initial hospital discharge.
次要结局
- Post Surgical Pain Intensity(2 days)
- Pre Surgical Pain Intensity(2 days)
- Length of Index Hospitalization(1 year)
- Adverse Effects and Complications(2-3 weeks)
- Medical Costs(1 year)
- Functional Outcome(1 year)
- Generic Health Status(1 year)
- Post Traumatic Stress (PTSD)(1 year)
- Depressive Symptoms(1 year)
- Fracture Classification(1-2 years)
- Fracture Severity(1-2 years)