Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Numeric Rating Scale(NRS)
研究概览
简要总结
This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-60 years of age
- •Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia
排除标准
- •Refusal to give consent.
- •Hypersensitivity or allergy to the study medication.
- •ASA physical status III or more.
- •Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block.
- •History of taking opioids or antiarrhythmic drugs within 1 week of surgery.
- •History of drug or alcohol abuse
- •History of psychiatric disorders.
- •Patients requiring emergency surgery.
- •Patients unable to comprehend pain assessment
研究组 & 干预措施
Lidocaine group
Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery
干预措施: Lidocaine (Drug)
Placebo
They will receive the same volume of 0.9% of normal saline as calculated for the experimental group
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Numeric Rating Scale(NRS)
时间窗: 24 hours
Pain at rest and with cough or movement using the NRS scale, which ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain
次要结局
- Total opioid consumption(24 hours)
- Time to first analgesic request(24 hours)
- Side effects(24 hours)
研究者
Dr Vivek Kumar Mahato
Post graduate resident in Department of Oral and Maxillofacial Surgery
B.P. Koirala Institute of Health Sciences