The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Postoperative consumption of narcotic in recovery room
研究概览
简要总结
The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).
Finally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old
- •ASA 1 or 2
- •First breast surgery
- •Unilateral breast cancer
- •Partial mastectomy or radical modified mastectomy ± axillary dissection
排除标准
- •Allergy or contrindication to any medication figuring in the protocol or to Aspirin
- •Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug
- •Narcotic consumption in the past month of 10 mg/day of morphine equivalent
- •Chronic pain
- •Moderate to severe asthma
- •BMI of more than 40
- •Chronic renal or hepatic faiure
- •Heart failure
- •Anticipated difficult airway
- •High grade heart block or bifascicular block
- •Mental retardation
研究组 & 干预措施
fentanyl
干预措施: fentanyl (Drug)
beta-blocker
Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control
干预措施: beta-blocker (esmolol, metropolol) (Drug)
结局指标
主要结局
Postoperative consumption of narcotic in recovery room
时间窗: Immediately after surgery
次要结局
- Pain level in recovery room(immediately after surgery)
- Occurence of nausea and vomiting in the recovery room(immediately after surgery)
- Chronic post-surgical pain(3 and 6 months)
- Reccurence of breast cancer(5 years)
- Time spent in recovery room(immediately after surgery)
研究者
Etienne de Medicis
Doctor
Université de Sherbrooke