NCT00847067终止不适用
A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To obtain practical experience and information with which to develop a larger, more definitive study, particularly with regard to distributions of VAS responses at 3 months, patient compliance, and achievable accrual rate.
研究概览
简要总结
The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the CNS during surgery and the immediate post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient who are ≥ 18 and ≤ 80 years of age.
- •Patient with diagnosis of breast cancer.
- •Patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection
- •Patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection
- •Patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction.
排除标准
- •Pre-existing peripheral neuropathy
- •Pre-existing chronic pain
- •Bilateral procedure
- •Previous breast surgery, except biopsy
- •Inability to read, write or speak English.
- •Allergy to amide local anesthetics
- •Contraindications to paravertebral nerve block including, but not limited to severe scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation studies (some of these may not be known until after informed consent is obtained)
- •Emergency surgery
- •Previous recipients of peripheral nerve block.
- •Medical professional whose experience includes caring for patients who have had peripheral nerve blocks.
结局指标
主要结局
To obtain practical experience and information with which to develop a larger, more definitive study, particularly with regard to distributions of VAS responses at 3 months, patient compliance, and achievable accrual rate.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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