Intravenous Lidocaine for Effective Pain Relief After Thyroidectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Postoperative pain measured using Visual analogue scale at postoperative 2hour
研究概览
简要总结
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.
A total 56 patients will be randomized into one of two groups(group C or group I) 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 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.
Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting 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
- •Total thyroidectomy
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)
Placebo control group
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 measured using Visual analogue scale at postoperative 2hour
时间窗: post op 2hour
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 24 hour(Post op 24 hour)
- visual analogue scale 8 hour(Post op 8 hour)
- Opioid consumption 4 hour(Post op 4 hour)
- visual analogue scale 4hour(post op 4 hour)
- visual analogue scale 24hour(Post op 24 hour)
- Opioid consumption 2hour(post op 2hour)
- FPB 2hour(Post op 2 hour)
- Visual analogue scale 12hour(Post op 12 hour)
- FPB 24hour(Post op 24hour)
- visual analogue scale 48 hour(Post op 48hour)
- Opioid consumption 8hour(Post op 8 hour)
- Opioid consumption 12 hour(Post op 12 hour)
- Opioid consumption 48 hour(Post op 48 hour)
- FPB 4hour(Post op 4 hour)
- FPB 12 hour(Post op 12 hour)
- FPB 8 hour(Post op 8 hour)
- FPB 48 hour(Post op 48 hour)
研究者
Hyun Kang
Assistant professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine