A Randomised Controlled Trial Comparing Ultrasound-guided Supraclavicular Brachial Plexus Block With Combined Supraclavicular and Pecs II Block in Patients Undergoing Arteriovenous Grafting Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Need for intraoperative local anaesthetic supplementation by the surgeon
研究概览
简要总结
This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular brachial plexus block in patients undergoing arteriovenous graft creation surgery. Participants will be randomised into two equal groups, one receiving supraclavicular and pecs II blocks, the other receiving supraclavicular block and sham block (Grade 1).
详细描述
Regional anaesthesia (RA) for arteriovenous grafting surgery has advantages of avoiding risks of general anaesthesia (GA) in this group of patients with significant co-morbidities, and beneficial vasodilatation, which may prevent early fistula thrombosis. Hence, RA is preferable to GA for this surgery.
Brachial plexus blocks (BPB) are the most commonly employed RA technique to anaesthetise the upper limb for this surgery. According to the results of a recent 2-year retrospective audit in our centre, ultrasound-guided supraclavicular BPB are the most popular RA technique for this surgery. Anatomically, the T1 and T2 dermatomes are often missed by the supraclavicular BPB. This means that the upper medial arm and axilla (sites involved in brachiobasilic and brachioaxillary arteriovenous grafting) may not be adequately anaesthetised, mandating intraoperative local anaesthetic supplementation by the surgeon. This may affect patients' and surgeons' acceptance of, and satisfaction with the RA technique. The ultrasound-guided Pecs II block, described by Blanco et al, seems to address this problem, as the intercostal T1-6, intercostobrachialis, long thoracic nerves and nerve to serratus anterior are targeted by this block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for arteriovenous grafting under regional anaesthesia in Changi General Hospital
- •American Society of Anaesthesiologists (ASA) physical status 3 to 4
- •Elective or emergency surgery
排除标准
- •Patients unable to give consent, unable to communicate or cooperate with simple instructions
- •Patients with regular consumption of strong opioids (eg. morphine, oxycodone) or steroids
- •Patients with allergy or contraindications to local anaesthetics or any of the drugs included in this study
- •Patients with pre-existing upper limb neurological deficits
- •Patients who refuse or are unsuitable for regional anaesthesia (eg. severely coagulopathic)
研究组 & 干预措施
Combined (C)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
干预措施: Supraclavicular (Procedure)
Combined (C)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
干预措施: Pecs II block (Procedure)
Combined (C)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
干预措施: Ropivacaine 0.5% 20ml (Drug)
Combined (C)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml and Pecs II block with Ropivacaine 0.5% 10ml.
干预措施: Ropivacaine 0.5% 10ml (Drug)
Supraclavicular (S)
Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
干预措施: Supraclavicular (Procedure)
Supraclavicular (S)
Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
干预措施: Sham block (Grade 1) (Procedure)
Supraclavicular (S)
Ultrasound-guided supraclavicular BPB with Ropivacaine 0.5% 20ml and sham block (grade 1)
干预措施: Ropivacaine 0.5% 20ml (Drug)
结局指标
主要结局
Need for intraoperative local anaesthetic supplementation by the surgeon
时间窗: Intraoperative
Whether there was a need for the surgeon to infiltrate a standardised local anaesthetic drug (0.5% ropivacaine) to the operative site during surgery
次要结局
- Volume of intraoperative local anaesthetic supplementation administered(Intraoperative)
- Need for additional sedation or systemic analgesia(Intraoperative)
- Highest pain score at Post-Anaesthesia Care Unit (PACU)(Up to 1 hour post-operatively)
- Time to first post-operative analgesia(Up to 24 hours post-operatively)
- Pain score at 12h(12 hours post-operatively)
- Pain score at 24h(24 hours post-operatively)
- Patient satisfaction at 24hours(24 hours post-operatively)
研究者
Kelvin Quek How Yow
Consultant
Changi General Hospital