Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,602
- 试验地点
- 24
- 主要终点
- Development of persistent pain 3-months after breast cancer surgery
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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)
研究组 & 干预措施
Intervention
Intraoperative intravenous lidocaine/placebo infusion
干预措施: Lidocaine 20mg/ml (Drug)
Control
Intraoperative intravenous lidocaine/placebo infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Development of persistent pain 3-months after breast cancer surgery
时间窗: 3- months
Persistent pain at 3-months
次要结局
- Opioid consumption(3 and 12 months)
- Pain intensities(3 and 12 months)
- Emotional functioning(3 and 12 months)
- Adverse events(3 and 12 months)
- Cost Effectiveness(3 months)
- Sensory and affective qualities of pain(3 and 12 months)
- Persistent neuropathic pain(3 and 12 months)
- Physical functioning(3 and 12 months)
- Moderate-to-severe persistent pain(3 and 12 months)
- Health-related quality of life quality of life(3 and 12 months)
- Cancer Recurrence(3 and 12 months)