A comparison of transdermal fentanyl patch 12.5 microgram versus 25 microgram for post operative analgesia in adults undergoing spine surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 2. First time of asking for rescue analgesia
研究概览
简要总结
The purpose of the study is to compare the efficacy of 12.5 mcg/h and 25 mcg/h fentanyl patches in controlling post operative pain in patients that undergo posterior spine stabilisation and instrumentation surgeries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and ASA 2 undergoing elective posterior spine instrumentation and stabilisation surgery under general anaesthesia.
排除标准
- •Opioid -dependent and sensitive patients, patients on antidepressant drugs, haemodynamically unstable, morbidly obese patients, peptic ulcers, uncontrolled systemic illness (Systemic hypertension and diabetes mellitus), impaired kidney or liver functions, history of intake of non-steroidal anti- inflammatory drugs or opioids within 24h before surgery or allergy to the used medications, coagulation defect, local infection at the site of application of transdermal patch, patient refusal will be excluded from the study.
结局指标
主要结局
2. First time of asking for rescue analgesia
时间窗: 30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours
3. Consumption of total Diclofenac and Tramadol consumption in 72 hours
时间窗: 30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours
4. Assessment of post operative sedation using Ramsay Sedation Score
时间窗: 30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours
1. Comparison of mean Numerical Rating Scale at different time intervals
时间窗: 30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours
次要结局
- 1. Post operative hemodynamics - Mean arterial pressure, heart rate(2. POst operative side effects - post operative nausea and vomiting, skin irritation and itching at the site of application of patch, hypotension, bradycardia, dyspnea, urinary retention)
研究者
Jamie Ann Varghese
Kasturba Medical College, Manipal