Three-level Injection Paravertebral Block Using Paravertebral Catheter Compared to General Anesthesia in Mastectomy Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative analgesia requirement (opioids + nonsteroidal antiinflammatory drug)
研究概览
简要总结
The purpose of the study is to investigate if paravertebral block for breast surgery may improve postoperative analgesia and shorten length of hospital stay. Within a prospective clinical trial sixty women (ASA I - III) undergoing unilateral mastectomy surgery with axillary dissection are enrolled. Exclusion criteria are general infection and local infection at the site of planned puncture, anatomic deformities of the thoracic spine, coagulation disorders, allergy against local anesthetics or contrast agents, pregnancy or breast-feeding and BMI ≥ 30 kg/m2.
Patients are randomly assigned to two groups, 30 patients each, by using block of four method. Group I patients receive paravertebral block at spine level Th 4 via catheter; Group II patients will have general anesthesia without nitrous oxide.
Paravertebral block (PVB) will be entirely performed by one person (1st author) with the patient in prone position. In randomly selected patients the catheter localization will be detected by fluoroscopy after injection of 0.5 ml contrast agent. The catheter positioned at about 8 cm from skin level, a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000 will be injected sequentially 10 ml each while withdrawing the catheter 2 cm after the first and again 2 cm after the second injection. Then the catheter will be removed. Low dose intraoperative sedation is provided with IV midazolam 2-3 mg, ketamine 0.5 mg/kg bolus and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1 - 1.5 mcg/mL to allow spontaneous breathing. In case surgical approach is not tolerated, the regional block is graded insufficient, and it is switched to general anesthesia.
At postoperative care unit (PACU) the pain score using visual rating scale (VRS) from 0 to 10 (worst imaginable pain) is assessed at rest and on movement of the shoulder every 15 minutes until 60 minutes. Analgesia is provided by IV morphine 0.04 mg/kg boluses with a 15-min dosing interval to maintain VRS - score < 3. Time to first analgesic demand and 24-hr analgesics consumption is recorded as well as postoperative nausea and vomiting (PONV). Complications are recorded including those related to the paravertebral block, such as Horner's syndrome, epidural spreading, hypotension that is not related to another. Patients will be checked 6, 12, and 24hr postoperatively for adverse effects, pain scores, and satisfaction scores.
详细描述
Multiple studies have shown that breast surgery is associated with significant postoperative pain, nausea, vomiting, and development of chronic pain. General anaesthesia is associated with a 50% incidence of nausea and vomiting among breast cancer surgery patients. The proposed benefits of regional anesthesia including paravertebral block compared to general anaesthesia are decreasing stress response, improving postoperative pain control and postoperative pulmonary function, decreasing cancer recurrence, and reducing thromboembolic events. However, the debate about these benefits is still controversial.
Paravertebral block for breast surgery, either alone or additional to general anaesthesia is favored by many investigators, due to better postoperative analgesia and shorter hospital stay. In an elder investigation thermographic imaging was used to apply paravertebral block. After a single injection of 15 ml 0.5% bupivacaine at spine level Th9-Th10 there was a mean distribution of somatic block of five and of sympathetic block of eight dermatomes without any hemodynamic side effects. No bilateral spread was found. The authors contradicted the suggestions paravertebral block being ineffective and sometimes hazardous. However, their patients were chronic pain patients with a number of six only.
Single-injection paravertebral block may not be sufficient to cover the relevant dermatomes C6 - Th6 for radical mastectomy with axillary dissection, when applied as the sole anesthetic technique. Some study groups performed paravertebral block with several injections. Four injections resulted in sufficient anaesthesia in 97% of these patients, whereas one injection was effective in only 11%. Though there is limited published evidence yet, a single injection for paravertebral block may be insufficient for extensive breast surgery, such as mastectomy including axillary evisceration. However, considering the potential risks of deep paravertebral puncture a limitation of punctures would be preferable. Inserting a paravertebral catheter far enough and in proper position offers the opportunity to apply the anesthetic agent at different sites, by moving the catheter backwards after each injection.
The purpose of our study is to find out if injections via paravertebral catheter at three different levels are advantageous and efficient compared to general anesthesia in patients having mastectomy with axillary dissection.
In addition, instead of 4 cm catheter insertion inside the paravertebral space (PVS) as the recommended, we used ultrasound-guided PVB (transverse view, out of plane technique), to facilitate further insertion of the catheter (8 cm) in the PVS. A contrast agent will be used in randomly selected patients to prove the exact site of the inserted catheter and to exclude/detect obstructions such as kinking.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Samples are collected after patients' written informed consent in accordance with the Declaration of Helsinki and institutional research board approval. Sixty women (ASA I - III) undergoing unilateral mastectomy surgery with axillary dissection (radical lymph node removal or sentinel node biopsy) are enrolled. Exclusion criteria are general infection and local infection at the site of planned puncture, anatomic deformities of the thoracic spine, coagulation disorders, allergy against local anesthetics or contrast agents, such as Iopamiro 300, pregnancy or breast-feeding and BMI ≥ 30 kg/m2.
排除标准
- •Patients who did not meet the inclusion criteria.
研究组 & 干预措施
general anesthesia
fentanyl 0,05 - 0.1 mg/h, propofol 150 - 200 mg, atracurium
干预措施: fentanyl, propofol, atracurium (Drug)
general anesthesia
fentanyl 0,05 - 0.1 mg/h, propofol 150 - 200 mg, atracurium
干预措施: sevoflurane and 50% oxygen in air (Drug)
paravertebral block
a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL
干预措施: paravertebral block (Procedure)
paravertebral block
a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL
干预措施: lidocaine , adrenaline, ketamine bolus, midazolam (Drug)
paravertebral block
a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL
干预措施: catheter with 3-level-injection (Device)
结局指标
主要结局
postoperative analgesia requirement (opioids + nonsteroidal antiinflammatory drug)
时间窗: 6 months (October 2013 - March 2014)
次要结局
未报告次要终点
研究者
Prof. Petchara Sundarathiti MD
Ramathibodi Hospital
Ramathibodi Hospital