Minimum Effective Local Anesthetic Volume of 0.5% Levobupivacaine Required for Ultrasound Guided Superior Trunk Block for Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity
研究概览
简要总结
The objective of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.
详细描述
Shoulder arthroscopic surgery is one of the most commonly performed procedures worldwide, and associated with significant postoperative pain. Currently, such surgery is performed either under general anaesthesia or under Interscalene brachial plexus block (ISBPB), which is a regional anaesthesia technique. However, ISBPB is associated with the highest incidence of hemi-diaphragmatic palsy of the operative side. Since majority of the innervation to the shoulder arises from or passes through the superior trunk of the brachial plexus, superior trunk block has been shown to have lesser impact on the phrenic nerve and it has been gaining popularity worldwide. Ultrasound is widely used for brachial plexus block and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks (superior, middle, and inferior trunks). However, there are no data describing an optimal volume of local anaesthetic for superior trunk block. The aim of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be blinded to the amount of local anesthetic agent used. Outcome assessor assessing the outcomes will be blinded of the amount of local anaesthetic used.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure
排除标准
- •Patient refusal
- •pregnancy
- •skin infection at the site of block placement
- •history of allergy to local anaesthetic drugs
- •bleeding tendency or with evidence of coagulopathy
- •pre-existing neurological deficit or neuromuscular disease.
研究组 & 干预措施
Levobupivacaine
Superior trunk nerve block will be done under ultrasound guidance to patients scheduled for shoulder surgeries. Local anesthetic agent (0.5% levobupivacaine) 8ml will be injected at the superior trunk of the brachial plexus in order to produce surgical anesthesia or analgesia for shoulder surgeries.
干预措施: 0.5% levobupivacaine (Drug)
结局指标
主要结局
Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity
时间窗: within 45 minutes after the block at 5 minutes interval
The first exact timing (in minutes) \[Readiness for surgery\] that an Overall sensory score =\<30 (NRS: 0-100; 100=normal sensation, 0=no sensation) using ice test and a motor grade =\<1 (3 point scale: 2=no block, 1=paresis, 0=paralysis) in the nerves (C5 to C6) tested that are supplied by superior trunk of brachial plexus. Sensation to coldness (ice) will be tested at C5 - Lateral (radial) side of the antecubital fossa (just proximal to elbow crease); C6 - Thumb, dorsal surface, proximal phalanx. Motor block will be graded using a 3-points scale: 2=no block, 1=paresis and 0=paralysis, and will be test at C5 - elbow flexors and C6 - wrist extensors. "Block failure" will be defined as inability to achieve "readiness for surgery" at 30 minutes after the completion of the block.
Minimum effective volume (ml) of local anesthetic agent
时间窗: after nerve block till end of surgery
The lowest volume (in milliliters) of local anesthetic agent that can produce an effective superior trunk block for surgery. Effective superior trunk block is defined as an overall sensory score of NRS =\<30 and a motor grade of =\<1 during the assessment after the nerve block that can undergo surgery. Sensory assessment will be done by using ice (cold sensation) test in both dermatomes (C5, C6) and a motor grade of =\<1 in both myotome (C5, C6) tested. Sensory block will be graded as 0 to 100 where 100 represents normal sensation and 0=no sensation to coldness (ice cube).
次要结局
- Discomfort score(assess once before surgery)
- Changes of motor blockade of the upper extremity(within 45 minutes after the block at 5 minutes interval)
- Paresthesia(during the period of undergoing the nerve block)
- Percentage changes of the Diaphragmatic function(Baseline (before block) and at 30 minutes after block)
- Changes of the Extensiveness of Diaphragmatic function(calculated after block)
- Changes of sensory block of the upper extremity(within 45 minutes after the block at 5 minutes interval)
- Block performance time(assess once before surgery)
- Complications(during the nerve block till the end of surgery)
研究者
Prof Manoj K Karmakar
Professor
Chinese University of Hong Kong