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临床试验/NCT06566664
NCT06566664
Enrolling By Invitation
不适用

Peripheral Neurostimulation for Nerve Block Placement

Stanford University1 个研究点 分布在 1 个国家目标入组 82 人2025年7月23日

概览

阶段
不适用
干预措施
B Braun HNS 12 nerve stimulator
疾病 / 适应症
未指定
发起方
Stanford University
入组人数
82
试验地点
1
主要终点
Onset of sensory block
状态
Enrolling By Invitation
最后更新
3个月前

概览

简要总结

Peripheral nerve blocks are routinely used and highly successful for intra-operative anesthesia and post-operative pain management. Nerve blocks are guided using either neurostimulation as a means to localize the right nerve or by ultrasound guidance or combining the 2 methods. The purpose of this study is to assess whether electrical stimulation improves nerve block quality, beyond its simple purpose of nerve localization.

详细描述

The investigators wish to understand how electrical stimulation can affect local anesthetic disposition when performing a peripheral nerve block. By studying this subject, the investigators open possibilities for improvement on many levels: increasing the efficacy of the nerve block allows for a reduced onset time, reduced incidence of incomplete block and prolonged duration of the local anesthetics. This allows for patients to fully benefit from the analgesic properties of the nerve block, allows for a decrease in delays for the operating room readiness, and a decrease in the amount of medication needed for a successful nerve block. This will decrease side effects and risks of the nerve blocks. Overall better post-surgical pain control may decrease risks for developing chronic post-operative pain, a major post-operative complication. The results of this study will open the door to novel approaches to manage acute post-operative pain.

注册库
clinicaltrials.gov
开始日期
2025年7月23日
结束日期
2026年7月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jean-Louis Horn

Professor of Anesthesiology

Stanford University

入排标准

入选标准

  • Undergoing elective upper limb surgery with a planned brachial plexus nerve block

排除标准

  • Under 18 years old
  • ASA score above III
  • Chronic pain condition with daily milligrams of morphine equivalent \> 30
  • Poorly controlled psychiatric condition
  • Coagulopathy
  • Active infection
  • Moderate, severe or progressing neuropathy
  • COPD/Chronic oxygen user
  • Pregnancy
  • Incarceration

研究组 & 干预措施

Ultrasound-guided brachial plexus block with peripheral nerve stimulation

Patients will receive a brachial plexus catheter with ultrasound guidance as per standard of care, with additional use of the B. Braun HNS 12 nerve stimulator during the loading dose of local anesthesia to maintain a gentle twitch.

干预措施: B Braun HNS 12 nerve stimulator

Ultrasound-guided brachial plexus block without peripheral nerve stimulation

Patients will receive the brachial plexus catheter in the same way the first arm would, and the B Braun nerve stimulator will be placed in the same way, but the ground electrode will not be connected to the patient.

干预措施: B Braun HNS 12 nerve stimulator sham control

结局指标

主要结局

Onset of sensory block

时间窗: Within 1 hour after the block placement

Determining time when patient experience first symptoms of local anesthetic action on the upper trunk distribution (median or musculo cutaneous nerve)

次要结局

  • Onset of motor block(Within 1 hour after the block placement)
  • Duration of sensory block(up to 7 days after surgery)
  • duration of motor block(up to 7 days after surgery)
  • When patient experience first pain(up to day 7 post operatively)
  • Time of first opioid taken(within the first 7 days after surgery)
  • Opioid usage at day 1(at post operative day 1)
  • opioid usage assessment at day 7(Within the Post operative day 1 and 7)
  • Opioid usage assessment at day 28(usage between post operative day 7 and 28)
  • Last opioid usage after day 28(Assessment within 1 year)
  • Amount of opioid usage after 28 days(28 days to 1 year after surgery)
  • Patient satisfaction(At Post Operative day 7, 28 and 1 year)
  • General satisfaction(at post operative day 7, 28 and 1 year)

研究点 (1)

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