Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. Patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. Chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. There is encouraging data suggesting that an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. A large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to determine the feasibility of undertaking such a trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients 18-75 years of age
- •undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast conserving surgery), for prophylactic (e.g. family history or BRCA gene mutation) or belief of isolated (non-metastatic) cancerous lesions
- •receiving a general anesthetic
排除标准
- •previous breast surgery within six months of index surgery
- •undergoing a DIEP (Deep Inferior Epigastric Perforator) flap procedure
- •patient has chronic pain or a chronic pain syndrome for which they have taken 4 or more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic, anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve blocks) during the past 3 months
- •documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine
- •history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block ≥ type II
- •history of congestive heart failure
- •renal insufficiency with creatinine > 120 µmol/L
- •known or previously documented cirrhosis
- •unable to swallow study medications
- •patient's surgeon believes patient is inappropriate for inclusion in trial
- •unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)
- •language difficulties that would impede valid completion of questionnaires
- •patient requires gabapentin or pregabalin for a medical condition or has been taking gabapentin or pregabalin daily during the past 1 week
研究组 & 干预措施
Pregabalin/Lidocaine
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
干预措施: Intraoperative Intravenous Lidocaine Infusion (Drug)
Pregabalin/Lidocaine
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
干预措施: Perioperative Pregabalin (Drug)
Pregabalin Placebo/Lidocaine
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
干预措施: Intraoperative Intravenous Lidocaine Infusion (Drug)
Pregabalin Placebo/Lidocaine
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
干预措施: Perioperative Pregabalin Placebo (Drug)
Pregabalin/Lidocaine Placebo
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
干预措施: Perioperative Pregabalin (Drug)
Pregabalin/Lidocaine Placebo
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
干预措施: Intraoperative Intravenous Lidocaine Placebo Infusion (Drug)
Pregabalin Placebo/Lidocaine Placebo
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
干预措施: Perioperative Pregabalin Placebo (Drug)
Pregabalin Placebo/Lidocaine Placebo
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
干预措施: Intraoperative Intravenous Lidocaine Placebo Infusion (Drug)
结局指标
主要结局
Feasibility
时间窗: 6 months
The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.
次要结局
- Post-mastectomy pain syndrome(6 months)
- Length of hospital stay(Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.)
- Quality of Life(3 months)
- Somatic Pre-occupation and Coping Scale(3 months)
- Acute postoperative pain(Postoperative days 1-9)