Onset and Duration of Forearm Nerve Blockade
2019年2月22日 更新者：Catherine Vandepitte, M.D.、New York School of Regional Anesthesia
Onset and Duration of Forearm Nerve Blockade Performed With a Single Distal Injection Versus Sequential Injections at Distal and Proximal Locations Alongside the Nerves: A Blinded Randomized
This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery.
Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm.
Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.
研究概览
研究类型
介入性
注册 (实际的)
36
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Limburg
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Genk、Limburg、比利时、B-3600
- Ziekenhuis Oost-Limburg
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
- American Society of Anesthesiologists (ASA) physical status I, II or III
- Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
- Scheduled to undergo primary hand surgery
- Able to understand the Dutch language, purpose and risks of the study
- Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments
Exclusion Criteria:
- Currently pregnant or nursing
- History of hypersensitivity to local anesthetics
- Contraindication to lidocaine, bupivacaine, paracetamol
- Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
- Suspected or known recent history (< 3 months) of drug or alcohol abuse
- Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments
- Infection at the planned block site(s)
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- Body weight <40 kg or body mass index >44 kg/m2
- Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity
- Any chronic condition or disease that would compromise neurological
- Presence of pre-existing coagulation disorders
- Baseline neurological deficits
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Lidocaine distal forearm
Lidocaine 1% - Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Lidocaine1%.
Volume injected is 6 mL/nerve; 12 mL total.
|
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
|
|
有源比较器：Bupivacaine distal forearm
Bupivacaine 0.5%-Ultrasound-guided specific blocks of the DISTAL median and ulnar nerves with perineural injections of Bupivacaine0.5%.
Volume injected is 6 mL/nerve; 12 mL total.
|
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
|
|
有源比较器：Lidocaine distal and proximal forearm
Lidocaine 1%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Lidocaine 1%.
Volume injected is 3 mL/nerve; 12 mL total
|
lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
|
|
有源比较器：Bupivacaine distal and proximal forearm
Bupivacaine 0.5%- Ultrasound-guided specific blocks of the DISTAL and PROXIMAL median and ulnar nerves with perineural injections of Bupivacaine 0.5 %.
Volume injected is 3 mL/nerve; 12 mL total.
|
Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
|
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 |
|---|---|---|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：5-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
5-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：10-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
10-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：15-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
15-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：20-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
20-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：25-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
25-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：30-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
30-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：45-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
45-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：60-minute beginning at the end of the last injection
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
60-minute beginning at the end of the last injection
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：Post Anesthesia Care Unit arrival
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
Post Anesthesia Care Unit arrival
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：15-minute after Post Anesthesia Care Unit arrival
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
15-minute after Post Anesthesia Care Unit arrival
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：30-minute after Post Anesthesia Care Unit arrival
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
30-minute after Post Anesthesia Care Unit arrival
|
|
onset of successful block and duration of sensory-motor blockade of the median and ulnar nerves
大体时间：Post Anesthesia Care Unit discharge
|
Block success is defined as full sensory block of the areas and muscles supplied by the median and ulnar nerves.
Block failure is defined as absence of sensory blockade at 30 min in the median and ulnar nerve territories as assessed by pin-prick, cold and light touch.
|
Post Anesthesia Care Unit discharge
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
postoperative Numeric Rating Scale (NRS)
大体时间：screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
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pain rating(numeric rating scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
screening Day0 (prior to the nerve block), post block, PACU arrival, Day0 evening, Day1 morning and evening, Day2 morning and evening, Day3 morning and evening, Day4, Day5, Day6, Day7
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：post block
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
post block
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Post Anesthesia Care Unit arrival
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Post Anesthesia Care Unit arrival
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 0 evening
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 0 evening
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 1 morning
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 1 morning
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 1 evening
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 1 evening
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 2 morning
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 2 morning
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 2 evening
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 2 evening
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 3 morning
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 3 morning
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 3 evening
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 3 evening
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 4
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 4
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 5
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 5
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 6
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 6
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 7
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 7
|
|
postoperative Numeric Rating Scale (NRS)
大体时间：Day 30
|
pain rating( Numeric Rating Scale) at rest and with movement ( scale 0:no pain - 10:worst pain)
|
Day 30
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月7日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2018年8月1日
首先提交符合 QC 标准的
2018年8月24日
首次发布 (实际的)
2018年8月28日
研究记录更新
最后更新发布 (实际的)
2019年2月26日
上次提交的符合 QC 标准的更新
2019年2月22日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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