A Randomised controlled trial of comparative study of the incidence of ipsilateral hemidiaphragmatic paresis after supraclavicular and costoclavicular brachial plexus block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Hemidiaphragmatic paralysis by M mode ultrasound,and measuring diaphragmatic excursion and peak expiratory flow rate
研究概览
简要总结
supraclavicular brachial plexus block is one of the common technique of anaesthesia for upper limb surgeries.One of the common adverse effect of supraclavicular brachial plexus block is ipsilateral hemidiaphragmatic paresis.
hfew studies have shown lower incidence of ipsilateral hemidiaphtrgamatic paresis (11.4%) following supraclavicular block,but the data is still insufficient,hence this study is planned to compare the incidence of ipsilateral hemidiphragmatic paresis between the supraclavicular and costoclavicular approach to brachial plexus block
It is a prospective,double blinded,randomised control trial,which has a primary objective to compare the incidence of hemidiaphragmatic paresis after supraclavicular nd infraclavicular block and secondary objective is to see the onset and duration and quality of sensory and motor block.we are recruting sample size of 60 ,30 in each group,satisfying all the inclusion criterias.GROUP A-Supraclavicular block with 30ml of 0.5% ropivacaine and GROUP B-Costoclavicular block with 30ml of 0.5% ropivacaine.
primary outcome will be measured by 1)M mode ultrasound to see the diaphragmatic excursion after 30 minutes and peak expiratory flow rate after the block post operatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of 18-60 years of age, of either sex posted for(elective/emergency) upper limb surgery.
- •ASA physical status 1,2 3)Patients with normal cardiorespiratory function.
排除标准
- •Refusal by patients for the procedure.
- •Known/suspected allergy to local anaesthetics.
- •Pregnant patients 4)Patients with body mass index more than 35kg/m2 5)Patients with neuromuscular disease 6)Patients with obstructive or restrictive pulmonary disease.
- •Patients with known/suspected phrenic nerve palsy or diaphragmatic dysfunction, other medical or anatomical contraindication to brachial plexus blockade.
- •Patients with deranged coagulation profile or having bleeding diathesis.
- •Evidence of local infection at the site of block 10)Patients with family history of neural disease.
- •Patients with opiod consumptions preoperatively.
结局指标
主要结局
Incidence of Hemidiaphragmatic paralysis by M mode ultrasound,and measuring diaphragmatic excursion and peak expiratory flow rate
时间窗: M mode ultrasound at 10 minutes interval after complete motor block and PEFR at 10 minutes interval
次要结局
- Onset, duration and quality of blockade.(At 15-30 minutes we assess sensory blockade in the Musculocutaneous(lateral forearm),radial(dorsal hand),median(thenar eminence) and ulnar(hypothenar eminence) distributions with respect to temperature, pressure and touch through Validated 3 point scale.)