Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- effectiveness of administering levo-bupicaine to control postoperative pain.
研究概览
简要总结
Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this study demonstrate the efficacy of administering a local anesthetic into the surgical bed of women operated radical mastectomy for breast cancer for the control of postoperative pain.
Material and methods: double-blind randomized clinical trial. The investigators recruited patients who underwent modified radical mastectomy that met inclusion and exclusion criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic and rescue medication was identical in both groups.
Statistical analysis: The baseline patient characteristics of the patients were analyzed by Chi square or Student t always meet criteria of normality, otherwise it will use the Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse events will be held on chi-square test.
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
- Double (Participant, Care Provider)
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
- •Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
- •Sign informed consent.
排除标准
- •Mastectomy without lymphadenectomy
- •Over 80 years
- •Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
- •Severe liver or kidney disease
- •Patients allergic or intolerant to any of the drugs used in the study protocol.
- •Regular users of analgesics or narcotics
研究组 & 干预措施
Control
Women of this group be infused saline 2 ml / h for 48h.
干预措施: Placebo (Drug)
levo-bupicaine
Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h.
干预措施: levo-bupicaine (Drug)
结局指标
主要结局
effectiveness of administering levo-bupicaine to control postoperative pain.
时间窗: 48 hours
the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad)
次要结局
- Decreased consumption of other analgesics(48 hours)