在乳腺癌手术中使用利多卡因输液预防持续性疼痛 (PLAN)
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
研究概览
详细说明
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alberta
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Calgary、Alberta、加拿大
- Foothills Medical Centre
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Edmonton、Alberta、加拿大
- Sturgeon Community Hospital
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Newfoundland and Labrador
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St. John's、Newfoundland and Labrador、加拿大
- Eastern Health- Health Sciences Centre
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Nova Scotia
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Halifax、Nova Scotia、加拿大
- IWK
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Ontario
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Hamilton、Ontario、加拿大
- Juravinski Hospital
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North York、Ontario、加拿大
- North York General Hospital
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Ottawa、Ontario、加拿大
- The Ottawa Hospital
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Thunder Bay、Ontario、加拿大
- Thunder Bay Regional Health Sciences Centre
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Toronto、Ontario、加拿大
- Mount Sinai Hospital
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Toronto、Ontario、加拿大
- Humber River Hospital
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Toronto、Ontario、加拿大
- St. Michael's Hospital
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Toronto、Ontario、加拿大
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、加拿大
- University Health Network
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Toronto、Ontario、加拿大
- Women's College Hospital
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Quebec
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Montreal、Quebec、加拿大
- Hôpital Maisonneuve-Rosemont
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Ile-Ife、尼日利亚
- Obafemi Awolowo University Teaching Hospitals Complex
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Dharān、尼泊尔
- B.P. Koirala Institute of Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥18 years old
- Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Exclusion Criteria:
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
- Known cirrhotic liver disease
- Pregnant
- Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 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 |
|---|---|
|
实验性的：Intervention
Intraoperative intravenous lidocaine/placebo infusion |
Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
其他名称：
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安慰剂比较：Control
Intraoperative intravenous lidocaine/placebo infusion |
Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).
其他名称：
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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 |
|---|---|---|
|
Development of persistent pain 3-months after breast cancer surgery
大体时间：3- months
|
Persistent pain at 3-months |
3- months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensities
大体时间：3 and 12 months
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Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement. |
3 and 12 months
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Opioid consumption
大体时间：3 and 12 months
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Morphine-equivalent opioid consumption |
3 and 12 months
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Moderate-to-severe persistent pain
大体时间：3 and 12 months
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Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours |
3 and 12 months
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Persistent neuropathic pain
大体时间：3 and 12 months
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Measured using the Douleur Neuropathique 4-symptoms interview |
3 and 12 months
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Sensory and affective qualities of pain
大体时间：3 and 12 months
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Quality of pain is reported using the Short Form McGill Pain Questionnaire |
3 and 12 months
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Emotional functioning
大体时间：3 and 12 months
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Emotional functioning is reported using the Profile of Mood States (POMS) |
3 and 12 months
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Physical functioning
大体时间：3 and 12 months
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Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form. |
3 and 12 months
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Health-related quality of life quality of life
大体时间：3 and 12 months
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Health-related quality of life will be assessed using EQ-5D-5L |
3 and 12 months
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Cancer Recurrence
大体时间：3 and 12 months
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Cancer recurrence will be assessed as a secondary outcome |
3 and 12 months
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Adverse events
大体时间：3 and 12 months
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Adverse Events will be monitored as a secondary safety outcome |
3 and 12 months
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Cost Effectiveness
大体时间：3 months
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Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed |
3 months
|
合作者和调查者
调查人员
- 首席研究员：James Khan, MD、University Health Network, Toronto
- 首席研究员：PJ Devereaux, MD.PhD、Population Health Research Institute
- 首席研究员：Ian Gilron, MD、Kingston Health Sciences Centre
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
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
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