Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Reduction of pain or paresthesia severity
研究概览
简要总结
In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.
详细描述
Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.
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
- None
入排标准
- 年龄范围
- 15 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poststernotomy chest pain and/or paresthesia
排除标准
- •Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.)
- •Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
- •Over production of scar tissue, thoracic surgery other than sternotomy -
- •Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass
研究组 & 干预措施
1
Gabapentin
干预措施: Gabapentin (Drug)
2
Diclofenac
干预措施: Diclofenac (Drug)
结局指标
主要结局
Reduction of pain or paresthesia severity
时间窗: one month
次要结局
- duration of relief of pain or paresthesia(three month)
