Comparison of Infraclavicular And Supraclavicular Block
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block
研究概览
地位
详细说明
In this prospective single-blind study, patients will be divided into 2 groups with the closed envelope method. Patients will be taken to the block application room before the operation. Standard monitoring (pulse oximetry, noninvasive blood pressure, ECG) will be applied to the patients. Premedication will be provided with 1mg IV midazolam after peripheral vascular access. Blocks will be performed by an experienced anesthesiologist under the guidance of USG and evaluated by another anesthesiologist who is blind to the block technique. After the antisepsis of the area, a 22G 100 mm stimulator needle will be used in the infraclavicular approach and a 22G 50 mm in the supraclavicular block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine plus 5 mcg adrenaline per ml will be used as local anesthetic mixture. The infraclavicular block will be applied by the lateral sagittal method under USG guidance. Supraclavicular block will be applied in the coronal oblique plane while the probe is placed on the clavicle. Following the blocks, the 5th, 10th, 15th, 20th, 25th, and 30th-minute sensory block levels, 10th, 20th, and 30th-minute motor block levels will be recorded. Sensory block level; Axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain). The motor block will be evaluated with a modified bromage scale: 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
Block success; At the 30th minute of LA application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.
Postoperative analgesia time; It will be considered as when the NRS(Numeric Rating Scale) is≥1.
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS scores at the 2nd, 6th, 12th, 24th hours.
Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time. Pain score during block application will be evaluated with the NRS. Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn. Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves. Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate satisfaction, 3 = full satisfaction, after the procedure. Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome. As rescue anesthesia, sedoanalgesia will be tried with remifentanil infusion, if it is not successful, general anesthesia will be started with a laryngeal mask. As postoperative analgesic regimen, patients will receive 3 x 1000 mg IV acetaminophen. As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia and the total dose of rescue analgesia for the first 24 hours will be recorded.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Mehmet E Şen, MD
- 电话号码:+905436838272
- 邮箱:m_emre_sen@hotmail.com
研究联系人备份
- 姓名:Zeki T Tekgül, Assoc Prof
- 电话号码:+905058554705
- 邮箱:zekitekgul@yahoo.com
学习地点
-
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Karabağlar
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Izmir、Karabağlar、火鸡、35170
- Izmir Bozyaka Training and Research Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18-65 years old
- ASA I-II
- Patients scheduled for hand, wrist, and forearm surgery
Exclusion Criteria:
- Uncoordinated patients
- Having a disease that prevents sensory block evaluation,
- Have coagulopathy,
- Known allergies to drugs to be used,
- Those with anatomical disorders at the application points
- Pregnant patients,
- Patients under 18 years of age,
- Patients with known local anesthetic allergy,
- Patients diagnosed with sepsis and bacteriemia,
- Skin infection at the injection site.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Supraclaviculer block
The coronal oblique supraclavicular block will be applied to the first group with ultrasound guidance using a 22G 50 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.) Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
The blocks will be performed by an experienced anesthesiologist with a USG guidence.
|
实验性的:Infraclaviculer block
The lateral sagittal infraclavicular block will be applied to the second group with ultrasound guidance using a 22G 100 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.).
Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
其他名称:
The blocks will be performed by an experienced anesthesiologist with USG guidence.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Block Formation Time
大体时间:30th minute pre-operatively
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Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves.
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30th minute pre-operatively
|
Block Application Time
大体时间:During Block Application
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Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn.
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During Block Application
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Block success
大体时间:At the 30th minute of LA application
|
Block success; at the 30th minute of local anesthesic application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves.
If any of these nerves are not blocked, it will be considered a failed block.
|
At the 30th minute of LA application
|
Sensory Block Level 5th minute
大体时间:5th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
5th minute
|
Sensory Block Level 10th minute
大体时间:10th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
10th minute
|
Sensory Block Level 15th minute
大体时间:15th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
15th minute
|
Sensory Block Level 20th minute
大体时间:20th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
20th minute
|
Sensory Block Level 25th minute
大体时间:25th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
25th minute
|
Sensory Block Level 30th minute
大体时间:30th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
30th minute
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The Motor Block Level 10th minute
大体时间:10th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
10th minute
|
Postoperative Analgesia Time
大体时间:24 hours post-operatively
|
Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is≥1.
|
24 hours post-operatively
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Pain Score Follow-up 2nd Hour
大体时间:2nd hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 2nd hour.
|
2nd hour
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Block Return Time
大体时间:24 hours postoperatively
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Sensory (the time from local anaesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anaesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time.
|
24 hours postoperatively
|
Patient and Surgeon Satisfaction
大体时间:Immediately after the surgery
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Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate dissatisfaction, 3 = moderate satisfaction 4 =full satisfaction, after the procedure.
|
Immediately after the surgery
|
Undesirable Side Effects
大体时间:24 hours postoperatively
|
Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome.
|
24 hours postoperatively
|
The Rescue Analgesia
大体时间:24 hours postoperatively
|
As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more.
The first time when the patient receives rescue analgesia will be recorded.
|
24 hours postoperatively
|
24-Hour Total Opioid Consumption
大体时间:24 hours postoperatively
|
The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded.
|
24 hours postoperatively
|
Pain Score Follow-up 6th Hour
大体时间:6th Hour
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Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 6th hour.
|
6th Hour
|
Pain Score Follow-up 12th Hour
大体时间:12th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 12th hour.
|
12th Hour
|
Pain Score Follow-up 24th Hour
大体时间:24th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 24th hour.
|
24th Hour
|
The Motor Block Level 20th minute
大体时间:20th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
20th minute
|
The Motor Block Level 30th minute
大体时间:30th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
30th minute
|
合作者和调查者
调查人员
- 学习椅:Mehmet E Şen, MD、Izmir Bozyaka Training and Research Hospital
- 学习椅:Zeki T Tekgül, Assoc Prof、Izmir Bozyaka Training and Research Hospital
- 学习椅:Taşkın Altay, Assoc Prof、Izmir Bozyaka Training and Research Hospital
出版物和有用的链接
一般刊物
- Gürkan Y, Hoşten T, Tekin M, Acar S, Solak M, Toker K. [Comparison of ultrasound-guided supraclavicular and infraclavicular approaches for brachial plexus blockade]. Agri. 2012;24(4):159-64. doi: 10.5505/agri.2012.38247. Turkish.
- Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SupraInfraTez
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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Bupivacaine HCl 0.5% Injectable Solution的临床试验
-
Guy's and St Thomas' NHS Foundation Trust招聘中
-
Washington University School of Medicine完全的