Study the efficacy of pre-emptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.
研究概览
简要总结
It is a Prospective, randomized, double blind comparative study to study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption. 60 patients planned for surgery under spinal anesthesia will be divided into 2 groups of 30 patients each: Group G (Pregabalin) and Group P (Placebo) - each given 1 hour prior to PCNL surgery. Other objectives include
To assess the VAS score Post operatively
To assess opioid consumption in first 24 hours To evaluate the time to first rescue analgesia
To assess the score of catheter related discomfort post operatively To asssess haemodynamic Parameters intra operatively and post operatively . To assess Ramsay sedation score intra operatively and post operatively To observe any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •ASA grade I or II fit patients.
- •Patients aged between 18 and 60 years of age.
- •Patients undergoing PCNL surgeries under spinal anesthesia.
- •Hemodynamically stable patients with all routine investigations within normal limits and without any comorbidities.
- •Written informed consent from the concerned patient.
排除标准
- •Patients who are not willing to participate in the study.
- •Patients with ASA grade III and above physical status.
- •Patients who are aged less than 18 and more than 60 years of age.
- •Patients who are posted for emergency procedures.
- •Patients with known allergy to the study drugs.
- •Patients who have psychiatric, coagulopathic, neurological, neuromuscular, or cardiovascular disease or impairment of hepatic or renal function.
- •Patients with coagulopathies and contraindication to Spinal Anaesthesia.
结局指标
主要结局
To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to reduce postoperative pain and analgesic consumption.
时间窗: Patients will be assesed on the level of pain they experienced using the 10 point Visual Analog Scale (VAS), along with Vital signs and Ramsay Sedation Score - post operatively at the end of suregery, 30 minutes, 2 hours, 6 hours, 12 hours and 24 hours. Opioid consumption, need of rescue analgesics and any adverse effects will be noted. Patients will also be assessed on the for any instrumentation induced discomfort/ catheter related discomfort at 0,2,6, 12 and 24 hours.
次要结局
- To study the efficacy of preemptive pregabalin in patients undergoing percutaneous nephrolithotomy to evaluate the time to first rescue analgesia & to observe any side effects(Patients will be assesed on the level of pain they experienced using the ten point Visual Analog Scale along with Vital signs & Ramsay Sedation Score intra operatively & post operatively The time to first rescue analgesia & any side effects will also be noted)
研究者
Samya Shrivastava
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE