Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage of patients who needed conversion to general anesthesia
研究概览
简要总结
INTRODUCTION: The axillary lymphadenectomy procedure is known to be associated with late postoperative complications, such as chronic pain and changes in shoulder mobility. Recently, several thoracic ultrasound guided interfascial blocks have been described, including serratus plane block. These blocks were associated with reduced postoperative pain scores in breast surgeries but were never evaluated in axillary dissection. The safety and feasibility of performing axillary dissection under local anesthesia and tumescent anesthesia associated with sedation has been demonstrated in case series, although it is not already the standard technique.
DISCUSSION: This project aims to investigate the feasibility of the serratus plane block associated with intra-venous sedation in a prospective case series including 15 patients submitted to axillary dissection, by scoring patient and surgeon satisfaction with the technique, pain, quality of life with EORTC QLQ-C30 questionnaire, and quality of recovery with QoR-40 questionnaire in the first 30 postoperative days.
详细描述
This study is a prospective case series. All patients should go through a preoperative evaluation with an anesthesiologist. At that time the eligibility for the study will be evaluated and if the patient consent to participate in the study.
The following parameters shall be evaluated in the ambulatory evaluation:
- Age
- Anthropometric data (weight and height);
- Presence of comorbidities;
- Revised cardiac index (LEE);
- Estimation of functional capacity in metabolic equivalents (METs) by history;
- Performance Status by the scale of Eastern Cooperative Oncology Group (ECOG);
- Determination of the physical status by the American Society of Anesthesiologists (ASA) classification;
- QoR-40 recovery quality scale, validated for Brazilian Portuguese;
- Quality of life EORTC QLQ-C30 questionnaire, validated for Brazilian Portuguese.
During the anesthetic procedure, the following standard technique should be applied: peripheral venous access, dipyrone 30 mg/kg, antibiotic according to the institutional protocol, moderate sedation with intravenous propofol in continuous infusion in the absence of any contraindication. Midazolam will be used in case of contraindication to propofol or during the execution of the block according to preference of the researcher who will perform the block. Associated with propofol infusion, the alpha agonist dexmedetomidine may be used in continuous infusion associated with fentanyl, tramadol, dextroketamine, magnesium sulfate, dipyrone and tenoxicam, whose uses will be evaluated on a case-by-case basis and will be recorded in the database.
In case of conversion to general anesthesia, the airway control should be carried out preferably with laryngeal mask, with the orotracheal intubation as an alternative option. The maintenance of anesthesia will be in this case using propofol continuous infusion in the absence of contraindications, otherwise sevoflurane will be used. Postoperative nausea and vomiting prophylaxis will be done with four milligrams of dexamethasone and ondansetron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergo axillary dissection due to metastatic skin or soft tissue cancer;
- •ASA physical status classification between I and III;
- •have signed the informed consent.
排除标准
- •weight less than 40 kilograms;
- •tumor affecting topography to be blocked;
- •presence of ulcerated lesion in the axilla;
- •presence of coagulopathy.
结局指标
主要结局
Percentage of patients who needed conversion to general anesthesia
时间窗: Intraoperative
Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.
次要结局
- The 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire.(Preoperative and in Postoperative day 30)
- QoR-40 questionnaire(Preoperative, First postoperative day visit and in Postoperative day 30)
- Surgeon satisfaction - 5 points Likert scale(Imediate postoperative period)
- Numeric pain rating scale (0-10)(Preoperative, postoperative day 1 and 30)
- Analgesic requirement(Intraoperative and postoperative day one (cumulative dose))
- Number of lymph nodes extracted(Postoperative day 30 (according to anatomopathological report))
- Patient satisfaction - 5 points Likert scale(First postoperative day visit)