Efficacy of Thoracic Paravertebral Block in Reducing Chronic Pain and Disability After Breast Cancer Surgery With Axillary Lymph Node Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.
研究概览
简要总结
The purpose of this study is to determine if the combination of thoracic paravertebral block and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing breast cancer surgery with lymph node dissection as compared to patients receiving local anesthesia with multimodal analgesia.
详细描述
Sixty percent of breast cancer patients undergo some form of breast surgery in the treatment of the early stages of the disease. The recovery from surgery can be associated with severe disabling pain persisting beyond 12 months after surgery. Research in pain has shown that early intervention of acute pain can prevent long term chronic pain.
At The Ottawa Hospital, patients receive either paravertebral blocks or wound infiltration with local anesthetic for postoperative pain management. We would like to compare these two methods of pain control to determine an analgesic technique that will reduce acute and chronic pain, and maximally improve long-term functional recovery and patient's quality of life.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of breast cancer
- •Scheduled for elective modified radical mastectomy, simple mastectomy with SLNB, breast conserving surgery (ie lumpectomy, segmental mastectomy) with ALND or ALND alone (after positive SLNB)
排除标准
- •American Society of Anesthesiologist (ASA) class 4 or 5
- •Patients with contraindications to TPVB
- •Allergy to study medications
- •Chronic opioid use defined as daily consumption of greater than 20 mg of oral morphine or equivalent for >7days
- •Renal insufficiency defined as a creatinine clearance <40ml/min as calculated using the Cockroft-Gault formula
- •Preoperative radiation therapy
- •Inability to achieve normal shoulder range of motion as defined as <100o of shoulder abduction or flexion
研究组 & 干预措施
Thoracic PVB + multimodal anesthesia
Thoracic PVB + multimodal anesthesia
干预措施: Thoracic Paravertebral Block (TPVB) (Procedure)
Local anesthetic + multi-modal analgesia
Local anesthetic + multi-modal analgesia
干预措施: Local Anesthetic (Procedure)
结局指标
主要结局
The Proportion of Individuals Reporting Chronic Postoperative Pain 12 Months Following Breast Cancer Surgery With Lymph Node Dissection.
时间窗: 1 year
次要结局
- Arm Morbidity, Shoulder Range of Motion, Quality of Analgesia, Arm Lymphedema, Time to Meet Discharge Criteria, Quality of Recovery, Quality of Life, Incidence of Postoperative Side Effects.(1 year)