Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) rating of pain
研究概览
简要总结
With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No cardiac and pulmonary diseases
- •No alcohol drinking.
排除标准
- •<19yrs, and >65yrs
- •History of central active drugs administration
- •Drug abuse
- •Hypertension
- •Any other chronic diseases.
研究组 & 干预措施
I
No drug was delivered.
干预措施: Saline (Drug)
II
Butorphanol tartrate 1mg was given intravenously.
干预措施: Opioid (Drug)
III
Butorphanol tartrate 2 mg was given intravenously.
干预措施: Opioid (Drug)
IV
Flurbiprofen Axetil 50 mg was given intravenously.
干预措施: NSAID (Drug)
V
Flurbiprofen Axetil 100 mg was given intravenously.
干预措施: NSAID (Drug)
VI
Tramadol Hydrochloride 10 mg was given intravenously.
干预措施: Opioid (Drug)
VII
Tramadol Hydrochloride 20 mg was given intravenously.
干预措施: Opioid (Drug)
结局指标
主要结局
Visual analog scale (VAS) rating of pain
时间窗: 0-24h after surgeries
次要结局
- VAS rating of sedation(0h to 24h after the end of the operation)
- Overall VAS rating of satisfaction with analgesia(24 h after operation)
- Incidence of side effects(From the initiation of analgesia (0 h) to the end of the study (24 h postoperative))
