NCT03278691招募中4 期
The Effect of Ketorolac on Posterior Thoracolumbar Spinal Fusions: a Prospective Randomized Controlled Trial
Ascension South East Michigan1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年10月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Fusion Construct X-Ray
研究概览
简要总结
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Elective thoracolumbar posterior lumbar instrumented interbody fusion
- •Minimally invasive spine surgery (MIS)
- •3 or fewer levels
- •Bone Morphogenetic Protein (BMP) use in interbody fusion (1.05mg/level or less)
- •Consent to study participation
排除标准
- •Active tobacco smoker or history of tobacco smoking in the past 6 weeks
- •Previous history of surgery at operative level(s)
- •History of chronic inflammatory/rheumatological condition
- •History of systemic steroid use in the past 3 months
- •Auto/Workers' compensation patients
- •Traumatic pathology at the operative levels
- •Infection at the operative levels
- •Tumor at the operative levels
- •Major psychiatric illness as diagnosed by psychiatrists and on major anti- psychotic/depressants
- •Patients on chemotherapeutic agents in the last 6 months
- •Patients who has a history of allergy to Ketorolac
- •Patients with a history of chemical addiction requiring professional rehabilitation and/or assistance
- •Patients with current creatinine > 1.5mg/dl
- •Patients with history of coagulopathy
- •Patients with history of hepatic impairment
- •Patients with uncontrolled cardiovascular disease
研究组 & 干预措施
Placebo
Placebo Comparator
Drug: Placebo Saline 1 ml IV Q6H
干预措施: Saline (Drug)
Intervention
Experimental
Ketorolac 15 mg (15mg/ml) IV Q6H
干预措施: Ketorolac (Drug)
结局指标
主要结局
Fusion Construct X-Ray
时间窗: 24 months postoperatively
Each fusion level will be evaluated individually and as part of the complete fusion construct. Fusion will be evaluated by blinded independent neuroradiologists using XR.
次要结局
- Visual Analogue Scale (VAS) for pain(Every 8 hours x 48 hours postoperatively)
- Quality of life - long term(12 months and/or 24 months postoperatively)
- Length of Stay (LOS)(12 months postoperatively)
- Morphine equivalent doses(12 months postoperatively)
- Complications/Adverse events(12 months postoperatively)
研究者
研究点 (1)
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