Combined General Anesthesia Plus Paravertebral Block Versus General Anesthesia Plus Opioid Analgesia for Breast Cancer Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post-operative analgesia consumption
研究概览
简要总结
This research project intends to look at the effect that a certain type of freezing injection, called a paravertebral block, has on the pain after an operation for breast cancer, the amount of pain relief that is needed and the side effects from this pain relief. The hypothesis is that the paravertebral block, in combination with a general anesthetic will reduce both pain scores and the amount of strong pain killers (opioids) that is needed. This will reduce the side effects of the pain killers such as nausea and vomiting.
This will be assessed by comparing it a general anesthetic with pain killers given through the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who agree to be involved in the trial, will be randomly allocated into two groups: both groups will receive a block, then a standardised and optimised general anesthetic. In one group however the block is simply a small injection under the skin (a sham block), whereas the other group will receive a proper paravertebral block prior to this. Both groups will receive opioids as necessary, depending on both their bodies reaction during the surgery and their pain scores when they wake up.
The paravertebral block is a very safe procedure with a very low side effect profile, and many studies have shown a benefit in breast cancer surgery. The investigators would like to assess this in our own practice. The block is normally inserted under some light sedation, with freezing into the skin initially. It is normally very well tolerated. The sham block will also be performed under light sedation and freezing into the skin. The patients will not be able to tell whether they are having the sham block or the paravertebral block, because both are very well tolerated. There are no potential complications from the sham block.
详细描述
Background Surgery for breast cancer can lead to a number of issues in the perioperative period. Both acute and chronic post-surgical pain are commonly encountered problems, with evidence that the degree of acute pain influences the likelihood of chronic pain. Post-operative nausea and vomiting (PONV) are also common, given the predominantly female surgical population and the requirement for opioid analgesia.
Paravertebral block (PVB) is an effective means of providing analgesia for mastectomy. A recent meta-analysis5 suggested that there is considerable evidence that paravertebral blocks with or without a general anesthetic (GA) provide superior post-operative analgesia to breast surgery operations done with a GA alone. There is also a reduced need for rescue analgesia and reduced opioid-related side effects. The results of this meta-analysis may be influenced by publication bias, and the results are difficult to interpret because the lack of standardisation of technique (single level injection, multi-level injection or continuous blockade via a catheter inserted into the paravertebral space) and the variety of the type and dosage of the local anesthetics used for the PVB. The meta-analysis does suggest that PVB is an effective technique for mastectomy with a minimal complication rate.
In our institution, the most common form of analgesia for mastectomy patients is systemic opioid analgesia. However, in the last two years, single level PVBs have been used with increasing frequency and reliable success. This is due in part to the use of ultrasound-guidance for placement of the PVB, which is a relatively simple technique with a well-defined end-point. The investigators have been using 0.2% ropivacaine, which was only mentioned in one study of the meta-analysis and was used with a multiple injection technique. The majority of studies used 0.5% bupivacaine, and most of these studies used PVB as the sole anesthetic technique. The next most common local anesthetic used was ropivacaine 0.5%, and this was more frequently used with multi-level injections. As the investigators use a single level injection in combination with a GA, these studies are not completely relevant to our current practice.
In this study, the investigators will compare PVB using Ropivacaine 0.2% combined with a GA, to GA alone with systemic analgesia.
Purpose The purpose of this study is to compare GA with systemic analgesia to GA with PVB. The parameters examined will be pain scores, perioperative opioid analgesia requirement, and PONV. Complications of PVB will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Over 18 years of age
- •Listed for Total Mastectomy +/- Axillary Node Dissection, or Partial Mastectomy
排除标准
- •Patient refusal or inability to give informed consent
- •Any contraindication for paravertebral blockade: coagulopathy, severe respiratory disease, local infection, untreated severe hypovolemia
- •Allergy to propofol, severe egg allergy, or allergy to local anaesthetic agents
- •Mastectomy plus flap reconstruction
- •Bilateral procedures
结局指标
主要结局
Post-operative analgesia consumption
时间窗: 24 hours post-surgery
Amount of morphine consumed in the 24 hours following surgery will be recorded
次要结局
- Post-operative pain(24 hours post-surgery)
- Pain upon movement(Within half an hour of return to recovery room)
- Intraoperative opioid requirement(During surgery)
- Nausea/vomiting(24 hours post-surgery)