Is There a Real Diaphragm-Sparing Nerve Block for Arthroscopic Shoulder Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- success of regional anesthesia procedure (no requirement of intraoperative general anethesia)
研究概览
简要总结
This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB), infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic nerve.
详细描述
Material and Methods This study will be performed according to the declaration of Helsinki. The institutional review board of the hospital (Clinique Médipôle Garonne, 45 rue de Gironis, 31036, Toulouse) gave its approval (registration n° 2016-202). Written consent for publication will been obtained from each patient.
Patients This prospective study will be conducted in the Department of Orthopedic surgery of Clinique Médipôle Garonne. Patients will be included from June 2017 to July 2017. Patients undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened. Exclusion criteria are: age <18 years, brachial plexus neuropathies, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medication of the study protocol and diabetes. All the patients will be operated on by the same surgeon (Dr Duport M.) and regional anesthesia will performed by experienced anesthetists (PM, CC, FF and MM).
Settings Before regional anesthesia (T1), the first sonographic evaluation of the diaphragm will performed.
All patients will be monitored in accordance with current guidelines, including non-invasive blood pressure as well as continuous electrocardiogram and pulse oximetry. The combination of infraclavicular brachial plexus block (ICB) (ropivacaine 0.375%, 20 mL), suprascapular nerve block (SSNB) (ropivacaine 0.375%, 5 mL) and supraclavicular nerve block (SCNB) (ropivacaine 0.375%, 5 mL) will performed. Systemic dexamethasone (10mg) will be administrated in all patients to prolong the analgesic effect of regional anesthesia. Shoulder arthroscopy will be performed in lateral decubitus position. Patients will then be transferred to the post-anesthesia care unit (PACU). Paracetamol (1 g each 6 hours) and Ketoprofen (100mg twice a day) will be systematically administered. Rescue analgesia with tramadol (100mg each 8 hours) will be administered if necessary (verbal rating scale (VRS) >3). Before PACU discharge (T2), a new ultrasonographic diaphragmatic function assessment will be done. Incidence of dyspnea will also be reported.
Patients will be contacted by phone once a day during the first two days after surgery to analyze the time period to the first opioids request, consumption of tramadol tablets and overall satisfaction. Patients will be instructed to keep a diary or write down the time when they took painkillers. Patient satisfaction concerning the procedure will be assessed using an 11-point scale (0: totally unsatisfied, I would definitively want a different anesthesia / analgesia method for the next surgery; 10: totally satisfied, I would definitively want the same anesthesia / analgesia method for the next surgery).
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.
排除标准
- •Exclusion criteria are: age <18 years, brachial plexus neuropathies, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medication of the study protocol and diabetes.
结局指标
主要结局
success of regional anesthesia procedure (no requirement of intraoperative general anethesia)
时间窗: 12 hours
The primary outcome is the success rate of regional anesthesia (i.e. intraoperative conversion to general anesthesia was considered as a regional anesthesia failure). General anesthesia was defined as requirement of intraoperative invasive ventilation.
次要结局
- diaphragmatic paralysis(12 hours)
研究者
Dr Marty Philippe
Dr Marty Philippe
Clinique Medipole Garonne
