The Analgesic Efficacy and Hemi-diaphragmatic Paralysis Assessment of Combined Infraclavicular-suprascapular Nerve Blocks Versus Standard Interscalene Brachial Plexus Block for Arthroscopic Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- The cumulative morphine consumption at first 24 hours postoperatively.
研究概览
简要总结
The aim of this trial is to compare the analgesic efficiency and hemi-diaphragmatic paralysis of the standard ultrasound-guided interscalene (ISB) brachial plexus block with the combined use of costoclavicular approach of infraclavicular brachial plexus block and suprascapular nerve block (ICB-SSB) for patients undergoing arthroscopic rotator cuff repair.
Authors hypothesize that the combined use of ICB-SSB could lead to equivalent postoperative analgesic effect to the standard ISB with less hemi-diaphragmatic paralysis.
详细描述
The interscalene block main hindrance is the high risk of ipsilateral phrenic nerve block with sequential hemi-diaphragmatic paralysis.The combined use of conventional paracoracoid infraclavicular block (ICB) and suprascapular block (SSB) was not equivalent to the standard ISB regarding the analgesic efficacy , but has no hemi-diaphragmatic affection for patients undergone shoulder arthroscopic procedures.ICB can be achieved by another approach (costoclavicular) which blocks the brachial plexus at the mid infraclavicular fossa The patients scheduled for an elective arthroscopic rotator cuff repair will be randomly allocated by a computer-gener¬ated table into one of two study groups. The randomization sequence will be concealed in opaque sealed envelopes. The envelopes will be opened by the study investigators just after recruitments and admission to the operation room. Only assessors and data collectors will be blinded to the groups allocations.
Preoperative preparation:
Preoperative investigations will be done according to the local protocol designed to evaluate the patients. It includes complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile and electrocardiogram (ECG).
Intraoperative Management of Patients:
After arrival to the induction room, a 20G intravenous catheter will be placed in the upper limb opposite to the surgical site, and intravenous premedication (midazolam 2 mg and fentanyl 50 µg) will be administered to all patients. Supplemental oxygen (nasal cannulae at 2 Lmin-1), standard ASA monitoring (5-lead ECG, noninvasive blood pressure (NIBP), and pulse oximetry) will be applied throughout the procedure. All blocks will be performed under real-time ultrasound guidance (Philips clear vue350, Philips healthcare, Andover MA01810, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •American Society association (ASA) physical status I to III patients who will be scheduled for an elective arthroscopic rotator cuff repair.
- •Exclusion Criteria
- •Patient refusal
- •preexisting (obstructive or restrictive) pulmonary disease or low baseline oxygen saturation
- •contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site).
- •hepatic or renal dysfunction.
- •Advanced cardiovascular diseases
- •chronic pain condition requiring the intake of opioids at home.
- •prior surgery in the neck or infraclavicular/suprascapular fossa.
排除标准
- 未提供
结局指标
主要结局
The cumulative morphine consumption at first 24 hours postoperatively.
时间窗: 24 hours after recovery from general anesthesia
in milligram
次要结局
- weight(6 hours before intervention)
- Incidence of paresthesia(within 1 second during performance of the blocks)
- Incidence of Horner syndrome(30 minutes after performance of the blocks.)
- Assessment of postoperative pain(48 hours after recovery from general anesthesia)
- Intraoperative fentanyl dose consumption(At the end of surgical procedure)
- Incidence of vomiting(24 hours postoperative)
- Incidence of respiratory depression(24 hours postoperative)
- time to first rescue analgesia(from recovery of general anesthesia up to 24 hours postoperativly)
- body mass index(6 hours before intervention)
- Assessment of hemidiaphragmatic paralysis by abdominal ultrasound examination(10 minutes after recovery from general anesthesia)
- Incidence of excessive sedation(24 hours postoperative)
- Incidence of local anesthetic toxicity(30 minutes after performance of the blocks.)
- height(6 hours before intervention)
- Assessment of hemidiaphragmatic paralysis(5 minutes after intervention)
- Incidence of complete sensory block(30 minutes after end of local anesthetic injection)
- Incidence of pruritus(24 hours postoperative)
- Incidence of urine retention(24 hours postoperative)
- duration of the surgical procedure(At the end of surgical procedure)
- Assessment of patients' satisfaction score for postoperative analgesia(after 72 hours postoperative)
- Interval morphine consumption dose(at 48 hours after recovery from general anesthesia)
- Incidence of complete motor block(30 minutes after end of local anesthetic injection)
- Incidence of nausea(24 hours postoperative)
- performance time of the intervention(1 minute immediately after end of local anesthetic injection)
- Incidence of vascular puncture(within 3 seconds during performance of the blocks)
- Incidence of hoarseness of voice(30 minutes after performance of the blocks.)
- Age(6 hours before intervention)
- Assessment of surgeon's' satisfaction score(At the end of surgical procedure)
研究者
Hany M Yassin, MD
Associate Professor of Anesthesiology
Fayoum University Hospital