Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
There is no consensus regarding which alternative is the best anesthesia for breast surgery, general anesthesia and morphine for postoperative analgesia or a combination of regional anesthesia and general anesthesia that possibly attenuates or abolishes the need for morphine.
The current study aims to determine which of the two strategies that is best in relation to postoperative pain, nausea and risk of recurrence of the disease.
详细描述
Surgery for suspected or confirmed breast cancer is a common procedure world wide. The Swedish National board of health- and welfare reports that > 7000 women is diagnosed with breast cancer each year in Sweden.
Surgery always comes at the cost of a painful stimuli. It is of great importance that the anesthetist has anticipated this pain and has a plan to handle it.
The most common way to do this is to anesthetise the patient (put him or her to sleep, also called a General Anesthesia (GA)) for the surgical procedure and administer a strong analgesic (usually morphine) before the patient is awaken. Morphine has side-effects.
Another possible plan is to rely on a Regional Anesthesia (RA) (block pain from a certain part of the body) to take care of the pain, both during and after the surgery. Thereby this patient may be awake during the surgery. The two strategies may also be combined. That is, a regional anesthesia is applied before surgery but the patient is also put to sleep. The regional anesthesia is then fully effective when the patient is awaken and no strong analgesics are administered. The approach with a regional anesthesia is common in orthopedic surgery, either in combination with or without a general anesthesia.
For surgery on the breast, there has been few alternatives available for regional anesthesia. They have been considered to invasive for regular use and not been incorporated in clinical praxis as a routine.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral surgery on the breast because of suspected malign disease.
排除标准
- •Bilateral surgery
- •Metastases other than in the axilla
- •Body Mass Index (BMI) > 35
- •Not able to communicate in Swedish
- •American Society of Anesthesiology (ASA) 4 or 5
- •Chronic pain treatment (use of opiates or medicine for neuropathic pain > 7 days the last month)
- •Known allergy to Morphine or Ropivacaine
- •Congestive Heart Failure, New York Heart Association (NYHA) IIIB or worse
- •Chronic renal failure (S-creatinine increased)
- •Immunosuppression (more than 10 mg daily of Prednisolone or stronger medication)
- •No axillary exploration planned
研究组 & 干预措施
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Ropivacaine 5 mg/ml, 35 ml (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Remifentanil 50 microg/ml (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Betamethason 4 mg (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Paracetamol 1,5 g (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Propofol (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Arcoxia, 120 mg (Drug)
GA with RA
Regional Anesthesia and General Anesthesia.
干预措施: Ondansetron 4 mg (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Remifentanil 50 microg/ml (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Betamethason 4 mg (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Paracetamol 1,5 g (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Propofol (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Arcoxia, 120 mg (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Ondansetron 4 mg (Drug)
GA without RA
Only General Anesthesia (without a supplemental Regional Anesthesia).
干预措施: Morphine (Drug)
结局指标
主要结局
All cause mortality
时间窗: 3 years and 5 years.
This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor.
Opiate consumption
时间窗: 48 hours
The cumulative consumption of opiates (Morphine). This is the most often used way to asses the efficacy of the regional anesthesia that the intervention consists of.
次要结局
- Chronic Pain(6 (5-7) months after surgery)
- Postoperative Nausea and Vomiting (PONV)(48 hours)
- Actual pain score(48 hours)
- Recurrence of breast neoplasm(3 and 5 years)