NCT01480765已完成4 期
Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
研究概览
简要总结
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Informed Consent
- •First time sternotomy for all cardiac surgery
- •Patient aged 18 - 80 years
排除标准
- •Emergency surgery (decision to operate taken on the day of surgery)
- •Previous sternotomy
- •Preoperative renal failure (eGFR <60 ml/min)
- •History of chronic non-anginal pain
- •Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
- •Concurrent use of oxycodone, lorazepam, or ethanol.
- •Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
- •Allergy to pregabalin, gabapentin or ketamine
- •Pregnancy
- •Limited understanding of numerical scoring scales
- •Previous participation in other trials investigating analgesic agents or any IMP in previous three months
研究组 & 干预措施
Control: Placebo + Placebo
Placebo Comparator
Placebo capsules and Placebo infusion
干预措施: Placebo capsules (Drug)
Control: Placebo + Placebo
Placebo Comparator
Placebo capsules and Placebo infusion
干预措施: Placebo infusion (Drug)
Pregabalin and Placebo infusion
Active Comparator
Pregabalin capsules and Placebo infusion
干预措施: Pregabalin (Drug)
Pregabalin and Placebo infusion
Active Comparator
Pregabalin capsules and Placebo infusion
干预措施: Placebo infusion (Drug)
Pregabalin + Ketamine infusion
Active Comparator
Pregabalin capsules + Ketamine infusion
干预措施: Pregabalin (Drug)
Pregabalin + Ketamine infusion
Active Comparator
Pregabalin capsules + Ketamine infusion
干预措施: Ketamine infusion (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
时间窗: 3 and 6 months post sternotomy
次要结局
- Total morphine consumption at 24 hours post surgery(24 hours post surgery)
- Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs(24 hours post surgery)
- Sedation (including pCO2) and nausea scores at 24 hours post surgery(24 hours post surgery)
- Side effect episodes (dizziness, confusion, blurred vision)(First 48 hours)
- Time to extubation(Post op recovery period)
- Length of stay in intensive care and hospital(Post operative - acute)
- 28 day mortality(28 days post surgery)
- Neuropathic pain score(3 and 6 months post surgery)
- Quality of Life(3 and 6 months)
- Survival(3 and 6 months)
- QST measurements(Pre op and post op at 72hrs and 3 months)
研究者
研究点 (1)
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