A study between three different ultrasound-guided techniques of Intercostobrachial nerve block - distal approach versus proximal approach versus supra-axillary approach in proximal humerus surgeries: A randomised three arm concurrent parallel clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the analgesic efficacy in terms of onset of sensory blockade of ultrasound
研究概览
简要总结
Proximal humerus fractures are usually managed surgically using various approaches. Among which delto-pectoral approach is commonly used because of its familiarity, reduced scarring and also incision can be extended as needed. The Intercostobrachial nerve (ICBN) originates from lateral cutaneous branch of 2nd intercostal nerve, then it pierces the intercostal and serratus anterior muscles and then crosses the axilla to medial side of the arm and provides sensory innervation to medial surface of arm.
This nerve is not consistently anaesthetized by standard brachial plexus blocks, leading to incomplete analgesia in anteromedial and posteromedial surface of arm during proximal humerus surgeries done by deltopectoral approach. Several approach to intercostobrachial nerve block exists, but the most effective method remains uncertain.
In this study, we hypothesise that USG Guided supra-axillary approach of ICBN block would provide better analgesia compared to distal and proximal approach of ICBN block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •ASA 1 and 2 BMI less than 30.
排除标准
- •Patients unwilling to enroll for the study Change in the plan of anaesthesia.
- •Patients with a history of allergy to the drugs used in the study Patients with infection at the site of injection.
- •Duration of surgeries extending beyond 3hrs.
- •Neuropathy.
结局指标
主要结局
To compare the analgesic efficacy in terms of onset of sensory blockade of ultrasound
时间窗: The Sensory block onset will be assessed every 2 minutes for 15 | minutes via pinprick testing over the anteromedial and posteromedial upper arm.
guided Intercostobrachial Nerve Block by three different approaches - distal approach
时间窗: The Sensory block onset will be assessed every 2 minutes for 15 | minutes via pinprick testing over the anteromedial and posteromedial upper arm.
versus proximal approach versus supra-axillary approach for patients undergoing
时间窗: The Sensory block onset will be assessed every 2 minutes for 15 | minutes via pinprick testing over the anteromedial and posteromedial upper arm.
proximal humerus surgeries done via delto-pectoral approach.
时间窗: The Sensory block onset will be assessed every 2 minutes for 15 | minutes via pinprick testing over the anteromedial and posteromedial upper arm.
次要结局
- To assess the ease of technique in terms of duration of procedure(Duration of the procedure will be recorded combining Landmark identification time (USG)
- To assess the incidence of ICBN block failures.(No sensory loss after 15 min after giving block will be noted)
- To assess analgesic efficacy post operatively using Visual analogue scale score.(post operatively at at 0,2,4,6,12,)
- To assess incidence of complications like hematoma, nerve injury and pneumothorax.(while administering the nerve block)
研究者
Thamizh Thendral
Aarupadaiveedu Medical college and research institute