Comparative Study of Ultrasound Guided Combined Interscalene and Supraclavicular Brachial Plexus Block Versus General Anesthesia for Brachioaxillary Surgery in Renal Failure Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- satisfaction of the patients to the combined block
研究概览
简要总结
The aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia.
详细描述
This randomized open blinded end-point pilot study was implemented at Mansoura University Hospitals. After acceptance of Institutional Research Board (No: MS/17.08.26), sixty patients of chronic renal failure, The American Society of Anesthesiologists (ASA) III, aged from 20 to 60 years old of either sex and planned for brachioaxillary graft interposition vascular surgery were enrolled.
Patients refusal, have allergy to local anesthetic, neurological, neuromuscular, psychiatric disorders, uncompensated hepatic, respiratory or cardiac disease, uncontrolled seizures, coagulation disorders, infection at the block injection site, body mass index more than 30 were excluded.
Written informed consents were obtained. Patients were classified using closed envelop method into two groups; group (GA) received general anesthesia; group (RA) received combined supraclavicular and interscalene block, each group were carried on 30 patients.
All patients were subjected to the preoperative assessment including history taking, clinical examination and assessment of ASA score. All patients subjected to dialysis session one day before the surgery. Basal laboratory investigation as complete blood count, coagulation profile (prothrombin time, international normalized ratio and activated partial thromboplastin time), arterial blood gases, Electrocardiography and echocardiography were done after dialysis.
After an overnight fasting, patients admitted to preanesthetic room where an intravenous (IV) cannula was inserted in the contralateral upper limb. Standard monitoring was applied to the patient include heart rate (HR), noninvasive blood pressure (NIBP), peripheral oxygen saturation (SpO2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sixty patients of chronic renal failure,
- •aged from 20 to 60 years old
- •of either sex
- •planned for brachioaxillary graft interposition vascular surgery were enrolled.
排除标准
- •Patients refusal,
- •have allergy to local anesthetic,
- •neurological, neuromuscular, psychiatric disorders,
- •uncompensated hepatic, respiratory or cardiac disease,
- •uncontrolled seizures,
- •coagulation disorders,
- •infection at the block injection site,
- •body mass index more than 30
研究组 & 干预措施
group GA (general anesthesia)
After pre-oxygenation general anesthesia was induced using 2mg/kg propofol, 1μg/kg of fentanyl. After loss of consciousness 0.5 mg/kg of atracurium was injected. The endotracheal tube (ETT) was placed and inflated. The patient was mechanically ventilated to adjust end tidal CO2 between 35 and 40mmHg, anesthesia was maintained using 1.2 % isoflurane diluted in 3L of 50 % oxygen mixed with air. Increments of fentanyl (0.5 μg/kg ) and atracurium 10 mg were used whenever required and the hemodynamic values were maintained within 20% of the basal values.
At the end of surgery, residual muscle relaxant was reversed with 50µg/kg neostigmine and 0.02 mg/kg atropine.
group RA (regional anesthesia)
received combined supraclavicular and interscalene block.The mixture of anesthetic suolution was prepared by 20 ml isobaric bupivacaine 0.5% plus 10ml lidocaine 2% plus 10ml normal saline, total volume was 40ml which is devided into 25ml for suraclavicular block and 15ml for intersalene block
干预措施: combined supraclavicular and interscalene block (Device)
结局指标
主要结局
satisfaction of the patients to the combined block
时间窗: 3 hours
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
graft potency
时间窗: up to one month after surgery
by doppler
Pain assessment by numerical rating scale
时间窗: 24 hours after surgery
was explained to all candidates (zero = no pain and 10 = the worst pain)
satisfaction of the surgeon to the combined block supraclavicular and interscalene during operation
时间窗: 3 hours
by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied
次要结局
- Number of times of needed analgesia(24 hours after surgery)
- The onset and duration of sensory and motor block(30 minutes after block)
- time to first intravenous analgesic requirement(24 hours after surgery)
研究者
Nevert Adel
MD Lecturer of Anesthesia and Surgical Intensive Care
Mansoura University