Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- postoperative pain scores using visual analogue scale
研究概览
简要总结
The primary objectives of this study are to analyse the effect of perioperative systemic infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and perioperative levels of inflammatory mediators in patients undergoing elective open abdominal surgeries.
The secondary parameters which will be observed during the study are the time to passage of flatus and stools postoperatively.
详细描述
Patients will be randomized into two groups- A and B, to receive an intravenous infusion of lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA) pump providing morphine. Postoperative pain scores will be noted at immediate postoperative and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea and vomiting is recorded. The time to first passage of flatus and stools postoperatively will be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6) will be noted in preoperative, immediate post operative and 24 hours post surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients above 18 years of age
- •undergoing elective open abdominal surgeries
- •belonging to the American Society of Anaesthesiologists (ASA)status I,II,III
排除标准
- •patients sensitive to lignocaine,
- •patients suffering from cardiovascular diseases or with preoperative changes on electrocardiogram
- •patients on beta blocker drugs
- •patients on opioid drugs for prolonged period
- •patients with functional bowel disorders
研究组 & 干预措施
intravenous lignocaine
Intravenous lignocaine will be given as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr throughout surgery and till one hour post surgery.
干预措施: Intravenous lignocaine (Drug)
normal saline
Normal saline will be given as a bolus at the time of intubation and saline infusion given to patients in the control group during the surgery and till one hour post surgery.
干预措施: Intravenous lignocaine (Drug)
结局指标
主要结局
postoperative pain scores using visual analogue scale
时间窗: till 24 hours post surgery
Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery
次要结局
- Number of patient controlled analgesia demands(Till 24 hours post surgery)
- Total amount of morphine consumed(till 24 hours post surgery)
研究者
Dr.P.Sridhar
Junior resident, Department of Surgery, Principal investigator
Jawaharlal Institute of Postgraduate Medical Education & Research