Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast
研究概览
详细说明
Regional analgesia techniques have shown to have benefits over conventional analgesia. The lower opioids analgesics requirements decrease side effects associated with the use of this type of medication. It is also increasingly established scientific evidence that reducing opioids administration may play a role in prognosis of cancer patients given the immunosuppressive effect of these drugs.
In patients undergoing oncologic/reconstructive breast surgery paravertebral block has been traditionally performed, however the paravertebral space lacks a clear anatomical barrier from the spinal cord so the drugs administered can diffuse to the intervertebral foramen causing deeper levels of blocks (epidural or spinal blocks) and injections at the paravertebral level are associated with serious complications both neurological and respiratory (meningitis, spinal hematomas abscesses, pneumothorax, respiratory failure. This has led to the development of less invasive technique with an improved safety profile.
The serratus plane block falls within the framework of these newly developed techniques and the present study aims to assess its role in the management of the patient undergoing cancer / reconstructive surgery.
Considering a decrease in postoperative morphine consumption of 40% and the average consumption of opioid after breast surgery under general anesthesia is 15 milligrams ( standard deviation 8 mg ) investigators calculated that with an alpha error 5% power 80 % 56 patients (28 per group) were required to achieve a significant result. In anticipation of possible loss of sample, 60 patients were recruited . Analysis will be performed by intention to treat.
Quantitative variables (opioid consumption, pain estimated by VAS scale) will be analyzed using mixed linear model adding a random variable for interindividual variability for pain threshold. If the data do not meet the criteria of normality the Mann-Whitney U test will be used. If the groups differ in preoperative variables. Investigators will make a multivariable analysis adjusting for these variables. The need for rescue analgesia over time is analyzed by Kaplan-Meier curve where the terminal state is the administration of the first dose of opioid postoperatively. The difference side effects (nausea, pruritus, apnea, urinary retention, ileus ) and complications IPO questionnaire and analyzed by chi-square test and Fisher exact test. Scheffe correction will be applied for multiple comparison. Missing data are excluded from analysis.
The study has planned data monitoring and auditing by the IIS la Fe according to AEMPS guidelines. Registries will be obtained from electronic medical records available for double check procedures.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Valencia
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Manises、Valencia、西班牙、46940
- Hospital de Manises
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients older than 18 years, undergoing oncological surgery and/or breast reconstruction surgery whose pathology and surgical intervention supose at least a 24 hours hospital admission
Exclusion Criteria:
- ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40). -Impossibility of anatomical structures ultrasound identification in a satisfactory way (there can be no distinction in the interfascial plane between serratus and pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the puncture site.
- Haemostasis disorders. - Allergy to any of the drugs used in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Serrato
Standard anesthesia+serratus plane block.
|
Serratus plane block.
|
安慰剂比较:Control
Standard anesthesia
|
Standard anesthesia
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Total Opioid Usage
大体时间:First 24 hours after surgery
|
Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg).
Opioid used will be fentanyl and morphine.
Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.
|
First 24 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pain at Rest and Coughing
大体时间:First 24 hours after surgery
|
Pain at rest and coughing at 24h postoperative (Visual analogue scale 0-10 with 0 meaning no pain and 10 meaning the worst imaginable pain).
High score mean worse outcomes
|
First 24 hours after surgery
|
Time to First Opioid Administration on the Ward
大体时间:First 24 hours after surgery
|
Time to first opioid administration on the ward
|
First 24 hours after surgery
|
Presence of Opioid Related Complications
大体时间:First 24 hours after surgery
|
presence of nausea/vomit or apnea or urinary retention or ileus is assessed.
It is a dicothomic composite (yes or no).
|
First 24 hours after surgery
|
合作者和调查者
调查人员
- 首席研究员:Guido Mazzinari、Instituto de Investigación Sanitaria La Fe
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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