Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Fusion rates
研究概览
简要总结
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
详细描述
Pain medicine literature and the principal investigator's anecdotal experience in posterior cervical and lumbar instrumented spine surgery suggest that pre-incisional IV ibuprofen significantly reduces postoperative pain without increasing surgical complications or fusion rate, which leads to earlier ambulation, less dependence on narcotic medications, shorter hospital stays, and earlier return to work. The purpose of this study is to assess if these anecdotal findings hold true in a randomized clinical trial of patients with cervical or lumbar spondylosis, who are undergoing decompression and instrumented fusion of the spine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age
- •Able to give consent
- •Diagnosed with spondylosis, stenosis, and/or instability of the cervical spine
- •Diagnosed with spondylosis, stenosis, and/or instability of the lumbar spine
- •Require a posterior decompression with internal fixation
- •Likely to complete the trial
排除标准
- •Patients with previous surgery at the treated spine segment
- •Women who are pregnant or plan to become pregnant during the study period Renal/liver disease
- •Anemia; coagulopathy
- •Thrombocytopenia (<30,000)
- •Coronary artery disease
- •Previous coronary artery bypass graft (CABG)
- •Patients taking Coumadin, Plavix, Lithium, or ACE-inhibitors plus Lasix; non-steroidal anti-inflammatory drug (NSAID) hypersensitivity
- •Gastric ulcers
- •Recent stroke
- •Traumatic brain injury, or intracranial surgery
研究组 & 干预措施
Intravenous (IV) normal saline
800mg normal saline before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain.
干预措施: normal saline (Other)
Intravenous (IV) ibuprofen
800mg IV ibuprofen before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Fusion rates
时间窗: 6 month post-operative
Assessed by plain x-rays or CT scans.
Change in overall health/function
时间窗: pre-operative, 1-3 weeks post-operative, 6 months post-operative
SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work.
Change in pain level
时间窗: pre-operative, 1-3 weeks post-operative, 6 months post-operative
Visual Analog Scale (VAS) scores at rest and with movement, Macqill Pain Questionnaire scores, and total morphine and morphine equivalents used during hospital admission.
次要结局
未报告次要终点
研究者
Lori Wood
Clinical Research Operations Manager
St. Joseph's Hospital and Medical Center, Phoenix