COMPARISON BETWEEN SELECTIVE BLOCKADE OF SUPRACLAVICULAR NERVES AND UPPER TRUNK OF BRACHIAL PLEXUS “THE SCUT BLOCK” AND CONVENTIONAL INTERSCALENE BLOCKS FOR CLAVICLE SURGERIES: A RANDOMIZED CONTROL TRIAL.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the post-op pain score - measured using Visual Analog Scale (VAS)
研究概览
简要总结
Regional anesthesia has been shown to improve patient outcomes in upper limb surgeries but a site specific approach for clavicle surgeries remain under developed. Traditionally the combination of interscalene brachial plexus block and superficial cervical plexus block has been used. however these techniques are not selective for clavicular innervation. Anatomical studies has identified four primary nerves responsible for clavicular sensation. They are superaclavicular nerve from the cervical plexus, nerve to subclavius, supra scapular nerve and long thoracic nerve from the brachial plexus.
SCUT that is supraclavicular and upper trunk blocks was developed to provide targeted anesthesia by selectively blocking the supraclavicular nerve and the upper trunk of brachial plexus. This study is prospective randomised double blinded controlled trial comparing the efficacy and safety of the SCUT block versus the conventional interscalene brachial plexus block in clavicle surgeries. The primary objective include evaluating postoperative pain score that is the visual analogue score and the incidence of diaphragmatic paralysis. While secondary objectives assess the opioid consumption that is the time fro the first opioid use and patient surgeon satisfaction.
A total of 120 patients will be randomised into two groups
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Group A. SSCUT block with 10 ml of 0.5% ropivacaine will be administered under ultrasound guidance
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Group B Interscalene and spra clavicular block using a larger volume of 20 to 30 ml of ropivacaine
Pain scores will be recored at time points intra operatively and post operatively. Respiratory function will be assessed using ultrasound at 1 and 6 hours post block. Statistical analysis will compare visual analogue scores, opioid use, patient satisfaction and complication rates.
This study aims to establish the SCUT block as a safer and more effective alternative to interscalene brachial plexus block by reducing the risk of diaphragmatic paralysis while providing adequate analgesia for clavicle surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18–70 undergoing clavicle surgery (e.g., open reduction and internal fixation • ASA (American Society of Anaesthesiologists) physical status I–III.
- •• Patients providing informed consent for participation in the trial.
排除标准
- •Patient refusal for surgery Bleeding diathesis Infection at the site of surgery Polytrauma.
结局指标
主要结局
To compare the post-op pain score - measured using Visual Analog Scale (VAS)
时间窗: till 12 hours post op
• To compare the incidence of diaphragmatic paralysis - associated with USG guidance.
时间窗: till 12 hours post op
次要结局
- To compare the post-op opioid consumption.(• To compare the patient satisfaction)
研究者
sripriyankaR
ACS Medical College and Hospital