Comparison Of Analgesic Efficacy Of Transdermal Buprenorphine For Postoperative Pain With Control Group In Patients Undergoing Lumbar Discectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To compare postoperative VAS score in patients receiving buprenorphine patch v/s control who wont receive buprenorphine patch
研究概览
简要总结
Transdermal patches for NSAIDS and opioids offer the advantage of sustained drug delivery, bioavailability, and avoidance of first-pass metabolism which reduces systemic effects. They have a one-time application, reduce workload on health-care workers, and prevent waxing-waning of analgesia due to diminishing blood levels.It has been widely applied in treating chronic low back pain displaying excellent results.This study is undertaken to see the effect of transdermal buprenorphine on postoperative pain after lumbar discectomy.
Patients posted for lumbar discectomy in Sapthagiri Institute of Medical Sciences who fulfil the inclusion criteria will be enrolled for the study. Patients will be randomised into 2 equal groups of 42 each [Group B and Group C] using computer generated table of random numbers.
Group B: Receiving transdermal buprenorphine patch 10 mg the night before surgery
Group C : Control group who will not receive buprenorphine patch
Group B patients will receive transdermal Buprenorphine 10mcg/hr patch night before surgery. Analgesia IV Paracetamol 1g will be given after intubation in both groups. Intraoperative hemodynamic parameters like HR , BP , SPO2 will be noted at baseline, induction, 5 mins and 10 mins. VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded. Inj Tramadol 2 mg/kg (maximum 100mg) IV will be administered when VAS>3 as rescue analgesic.VAS score, time of first rescue analgesia, total analgesic consumption will be recorded in first 48 hours and compared between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 grade I and II Age 18-60yrs Posted for lumbar discectomy.
排除标准
- •Patients not willing to participate in the study Patients on any other form of opioid therapy for chronic pain History of drug allergy or application.
结局指标
主要结局
To compare postoperative VAS score in patients receiving buprenorphine patch v/s control who wont receive buprenorphine patch
时间窗: VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded
次要结局
- Time to first rescue analgesic.(Total rescue analgesic.)
研究者
Lekha Shree R
Sapthagiri Institute Of Medical Sciences And Research Centre
