Comparison of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation for Effective Pain Relief After Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Postoperative pain measuring using Visual analogue scale at postoperative 2hour
研究概览
简要总结
This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy.
A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation.
Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic cholecystectomy
排除标准
- •mental change
- •allergy to local anesthetics
研究组 & 干预措施
Intravenous lidocaine injection group
Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
干预措施: Intravenous lidocaine injection (Drug)
Intraperitoneal lidocaine irrigation group
Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc.
干预措施: Intraperitoneal lidocaine irrigation group (Drug)
Intravenous normal saline group
The patients in Group C (placebo control group) received normal saline intravenous injection
干预措施: Intravenous normal saline injection (Drug)
结局指标
主要结局
Postoperative pain measuring using Visual analogue scale at postoperative 2hour
时间窗: Post op 2 hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 2hour.
次要结局
- Opioid consumption 8 hour(Post op 8 hour)
- Opioid consumption 12 hout(Post op 12 hour)
- Opioid consumption 24 hour(Post op 24 hour)
- Opioid consumption 48hour(Post op 48 hour)
- FPB 2 hour(Post op 2 hour)
- FPB 4 hour(Post op 4 hour)
- FPB 8 hour(Post op 8 hour)
- FPB 12 hour(Post op 12 hour)
- FPB 24 hour(Post op 24hour)
- FPB 48 hour(Post op 48 hour)
- Visual analogue scale 4hour(Post op 4 hour)
- Visual analogue scale 8hour(Post op 8 hour)
- Visual analogue scale 12 hour(Post op 12hour)
- visual analogue scale 24hour(Post op 24hour)
- Visual analogue scale 48 hour(Post op 48hour)
- Opioid consumption 2hour(Post op 2 hour)
- Opioid consumption 4 hour(Post op 4 hour)
研究者
Hyun Kang
Assistant professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine