Quality of Recovery After Primary Breast Cancer Surgery Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
Quality of Recovery After Primary Breast Cancer Surgery: A Prospective, Multicentre, Randomized, Triple-Blinded Trial Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
The goal of this clinical trial is to learn whether an intravenous lidocaine infusion (IVLI) works as well as a thoracic paravertebral block (TPVB) - the current standard nerve-block technique - for improving recovery after breast cancer surgery. It will also learn about the safety of both approaches. The main questions it aims to answer are:
Does IVLI provide a similar quality of recovery (measured by the QoR-15 score at 24 hours) as TPVB? Does IVLI control pain during the first 24 hours after surgery (measured at rest and with arm movement) as well as TPVB?
Participants will:
Undergo their planned breast cancer surgery (mastectomy or breast-conserving surgery with sentinel lymph node biopsy) under general anaesthesia, along with either the TPVB injection or the IVLI infusion, assigned at random Attend a preoperative visit the day before surgery to learn how to use the pain and self-quality-of-recovery questionnaire (QoR-15) Fill out a QoR-15 once a day for the first 48 hours after surgery Participants' pain score in hospital recorded during the first 48 hours after surgery, with rescue pain medication available if needed
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Chayapa Luckanachanthachote
- 电话号码:+66 928266963
- 邮箱:chayapa.anes@gmail.com
学习地点
-
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Bangkok
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Bangkok Noi、Bangkok、泰国、10700
- Mahidol university
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接触:
- Mahidol University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult ASA I-III patients between the age 18 to 75 years scheduled for primary breast cancer surgery-simple mastectomy and modified radical mastectomy with sentinel lymph node biopsy +/- axillary dissection.
Exclusion Criteria:
- Patient refusal, patients unable to comprehend QoR15 form, total body weight less than 40 Kg, local skin site infection, coagulopathy, history of allergy to local anaesthetics, and patients with hepatic, renal and cardiac dysfunction will be excluded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:TPVB
US guided TPVB
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Single shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg/ml (total mixture 25 ml)
infusion of normal saline at a same rate as IV LI (0.075ml/kg in 10 mins then 0.075ml/kg/h)
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实验性的:IV LI
IV Lidocaine infusion
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Patients receiving IV Lidocaine infusion of 1.5 mg/kg in 10 mins then continue 1.5mg/kg/h (= 0.075ml/kg in 10 mins then 0.075ml/kg/h) intraoperatively
2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of recovery 15 (QoR15) score at 24 hours
大体时间:From enrollment to 48 hours postoperatively
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Patient-reported QoR 15 at 24-hour and 48-hour postoperative
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From enrollment to 48 hours postoperatively
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合作者和调查者
调查人员
- 首席研究员:Chayapa Luckanachanthachote, MD、Mahidol university
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 102/2569(IRB4)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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