NCT01499836已完成4 期
Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
Nai Liang Li2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- quality of recovery
研究概览
简要总结
Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has a physical status between ASA I and III
- •18 - 70 years of age
- •Patients able to read a newspaper in Chinese.
- •Elective unilateral wide excision/simple mastectomy and SLNB/ALND
- •Patient has signed an informed consent
- •Without contraindication of GA or PVB
- •Body mass index (BMI) less than 24 kg/m2
排除标准
- •ASA > III
- •inability to provide informed consent
- •Bleeding disorders
- •Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Allergy to amide-type local anesthetics or NSAIDs
- •Infection at the thoracic paravertebral injection site
- •Pregnancy or breast-feeding
- •Severe spine or chest wall deformity
- •body mass index equal to or more than 24 kg/m2
- •patients with major psychosis or drug and alcohol abuse
- •patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
- •Patients with significant visual impairment or other physical disability that precludes complete cooperation
结局指标
主要结局
quality of recovery
时间窗: postoperative 6 hour and postoperative day(POD)1
次要结局
- adverse events(POD1)
- NRS pain score(postoperative 1 hour, 6 hour, and POD1)
- Number of patients with a technique failure of the PVB(during operation)
- Satisfaction(POD1)
研究者
Nai Liang Li
M.D.
Sun Yat-sen University
研究点 (2)
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