A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.

Mayo Clinic1 个研究点分布在 1 个国家目标入组 40 人2009年2月

适应症Breast Cancer

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Breast Cancer
发起方: Mayo Clinic
入组人数: 40
试验地点: 1
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.
状态: 终止
最后更新: 15年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2009年2月

结束日期

2010年4月

最后更新

15年前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Mayo Clinic

入排标准

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