Effectiveness of a Single preoperative low dose of Gabapentin 100mg in reducing postoperative pain in varicose vein surgery.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- comparison of post operative pain in patients taking single pre op dose of gabapentin and preop placebo
研究概览
简要总结
Minimally invasive Varicose veins surgery is a standard of care for dilated incompetent leg veins. However, patients often have a low-grade postoperative pain which leads to poor patient satisfaction.
Gabapentin, an NMDA receptor modulator, has been used to modulate postoperative pain as a preemptive agent. The study is designed as a randomized control trial to evaluate prevention of postoperative pain with gabapentin.
Patients undergoing varicose vein surgery who fulfill the inclusion criteria will be enrolled in the study. Pre operative pain score will be evaluated using Numeric Rate Score. Patients will be divided into two groups by random allocation.
Group A will receive 100 mg of Gabapentin Suspension 2 hours prior to surgery.
Group B will receive a placebo 2 hours prior to surgery.
All patients will undergo surgery under spinal anesthesia. They will receive 0.5% heavy Bupivacaine (Hyperbaric) with 25mcg Fentanyl.
After surgery, patients will be assessed for post operative incidence of pain using Numeric Rate Score, sedation with Ramsay sedation score and post operative nausea and vomiting at regular intervals for first 24 hours.
Post operatively all patients will receive Tablet Paracetamol 1gm per oral every 6hrly. Break through pain will be managed with subcutaneous Inj. Morphine 0.1mg/kg for the first 24 hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a) All ASA 1 and 2 patients for varicose vein surgery b) Age between 18 to 60 years.
排除标准
- •a)Patient refusal b)ASA more than 3 patient c)Ideal body weight less than 50 kg d)Allergic to Gabapentin e)Patient on antiepileptics f)Contraindication to opioids and paracetamol.
结局指标
主要结局
comparison of post operative pain in patients taking single pre op dose of gabapentin and preop placebo
时间窗: will be assessed at 4hrs after giving spinal anaesthesia then every 1hrs for first 24 hrs.
次要结局
- a.To measure the Sedation using Ramsay sedation scale in the postoperative period(b.To calculate the total requirements of analgesia used in first 24 hours postoperatively.)
研究者
Arul Nirmal Raj S
christian medical college vellore