跳至主要内容
临床试验/NCT00519246
NCT00519246已完成4 期

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

No drug was delivered.

干预措施: Saline (Drug)

II

Active Comparator

Butorphanol tartrate 1mg was given intravenously.

干预措施: Opioid (Drug)

III

Active Comparator

Butorphanol tartrate 2 mg was given intravenously.

干预措施: Opioid (Drug)

IV

Active Comparator

Flurbiprofen Axetil 50 mg was given intravenously.

干预措施: NSAID (Drug)

V

Active Comparator

Flurbiprofen Axetil 100 mg was given intravenously.

干预措施: NSAID (Drug)

VI

Active Comparator

Tramadol Hydrochloride 10 mg was given intravenously.

干预措施: Opioid (Drug)

VII

Active Comparator

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))

研究者

发起方
Nanjing Medical University
申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Comparison of Pain Therapeutic Effects After Benign... | 临床试验