Comparison of Ultrasound guided out-of-plane vs in-plane Costoclavicular block approach in children undergoing unilateral upper extremity surgery- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To compare the mean needling time in out-of-plane and in-plane approaches of ultrasound guided costoclavicular brachial plexus block for upper limb surgeries in paediatric patients aged 2 to 10 years.
研究概览
简要总结
Patients fulfilling the inclusion criteria will be confirmed by anaesthesiologist during pre Anesthetic checkup. Patients will be randomised into one of the two groups based on the approach to the costoclavicular block IN PLANE or OUT OF PLANE using computer generated random number table. Group allocation will be carried out using sealed enveloped technique.
Under aspectic precautions the ultrasound probe will be placed inferior and parallel to the clavicle to obtain the view of costoclavicular space. From medial to lateral, beneath the subclavius muscle a clear Image of axillary vein artery and brachial plexus cords will be considered as ideal for perineal injection . A 22G 5cm needle will be attached to the nerve simulator.
In IP group after identifying the costoclavicular space the needle will be advanced in plane from lateral to medial side aiming to enter the sheath of brachial plexus.
In OP group after identifying the costoclavicular space the needle will be advanced out of plane through the pectoralis muscle and subclavius with watch on the plural to enter the sheath of brachial plexus.
In both the groups the proximity to the cords will be identified based on the motor response to nerve stimulation and 0.5 ML per KG of 0.2 percent ropivacaine will be injected after negative aspiration of blood.
Surgeons will be requested to make the skin incision after 20 minutes of administration of the block. A rise in heart rate/BP more than 20
Percent will be considered as block failure and one microgram per KG of fentanyl will be administered intravenously.
In the PACU Post operative pain will be assisted using FLACC score in children less than seven years and vAS pain score in children. more than seven years. Pain will be assisted on arrival and in 15 minutes 30 minutes two hours six hours after arrival to the PACU.
In this study the primary outcome will be measured by the needling time which is the time taken from skin puncture to obtaining an acceptable motor response at 0.5 mA on peripheral nerve locator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 2 to 10 years of age
- •Scheduled for unilateral surgery of elbow, forearm, wrist or hand under general anesthesia
- •ASA physical status I/II.
排除标准
- •Patients requiring simultaneous contralateral upper extremity surgery or skin/bone grafting
- •Preexisting neurological deficit
- •History of previous surgery or trauma at the block area
- •Local site infection
- •H/O known allergy to local anaesthetics
- •Bleeding diathesis
- •Refusal of consent/assent
- •ASA physical status III/IV.
结局指标
主要结局
To compare the mean needling time in out-of-plane and in-plane approaches of ultrasound guided costoclavicular brachial plexus block for upper limb surgeries in paediatric patients aged 2 to 10 years.
时间窗: At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during the performance of ultrasound guided costoclavicular block
次要结局
- To compare the ease of needling between the two groups
- To compare number of skin punctures between the two groups(At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of ultrasound guided costoclavicular block)
- To compare the number of needle manipulations to obtain a complete local anaesthetic spread between the two groups(At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of ultrasound guided costoclavicular block)
- To compare the success rate that is absence of increase in heart rate or blood pressure more than 20 percent from baseline during skin incision between the two groups(At time points 15,20,25,30 minutes during performance of ultrasound guided costoclavicular block)
- To compare the postoperative pain scores between the two groups(In PACU on arrival,5mins,30mins,2hrs,6hrs after arrival to the postoperative room)
- To compare the duration of postoperative analgesia between the two groups(In PACU at time points 15,30,45,60,75,90 minutes & every 15 minutes till 6hrs postoperatively.)
- To compare the complications between the two groups(At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of costoclavicular block through intraoperative period,in postoperative period every 15minutes till 6hrs.)
研究者
Rajashree Deka
All India Institute of Medical Sciences