Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Sensory Block, as assessed by hollman scale for pinprick test
研究概览
简要总结
This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups
详细描述
Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for upper extremity surgery with infraclavicular nerve block
排除标准
- •Patient Refusal
- •Patients younger than 18
- •Patients with known local anesthetic allergies
- •Patients with a BMI>30
- •Diabetic Patients
- •Uncooperated Patients
- •Patients with coagulopathy or recieving anticoagulant therapy
- •Skin infection on injection site
- •Patients diagnosed with sepsis or bacteremia
- •Physiologic and emotional lability
- •Surgeries that are expected to last longer than 3 hours
研究组 & 干预措施
Concentrated
Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group
干预措施: Bupivacaine 0.25% (Drug)
Concentrated
Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group
干预措施: Prilocaine 1% (Drug)
Concentrated
Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group
干预措施: Infraclavicular Nerve Block (Procedure)
Concentrated
Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group
干预措施: Ultrasound (Device)
Diluted by 33%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group
干预措施: Infraclavicular Nerve Block (Procedure)
Diluted by 33%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group
干预措施: Bupivacaine 0.167% (Drug)
Diluted by 33%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group
干预措施: Prilocaine 0.66% (Drug)
Diluted by 33%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group
干预措施: Ultrasound (Device)
Diluted by 50%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group
干预措施: Infraclavicular Nerve Block (Procedure)
Diluted by 50%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group
干预措施: Bupivacaine 0.125% (Drug)
Diluted by 50%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group
干预措施: Prilocaine 0.5% (Drug)
Diluted by 50%
Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group
干预措施: Ultrasound (Device)
结局指标
主要结局
Sensory Block, as assessed by hollman scale for pinprick test
时间窗: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute
Sensorial response to pinprick will be assessed at innervation sites of ulnar median radial and musculocutaneous nerves. Innervation sites of assessment are volar skin of the fifth finger for ulnar nerve, volar skin of second finger for median nerve and dorsal, proximal of the second finger for radial nerve and skin of the anterolateral forearm for musculocutaneous nerve.
Motor Block, as assessed by hollman scale for motor blockade
时间窗: 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute
Motor function for each nerve will be assessed. Movements to be evaluated are; abduction of the fingers for ulnar nerve, thumb opposition for median nerve, extension of the forearm for radial nerve and flexion of the forearm for musculocutaneous nerve.
Postoperative Sensory Block, as assessed by hollman scale for pinprick test
时间窗: 1th hour in PACU
Postoperative Motor Block, as assessed by hollman scale for motor blockadet
时间窗: 1th hour in PACU
次要结局
- Pain, as assessed by visual analogue scale(1st hour and 6th hour)