MedPath

Peripheral Neurostimulation for Nerve Block Placement

Not Applicable
Not yet recruiting
Conditions
Pain Syndrome
Interventions
Device: B Braun HNS 12 nerve stimulator sham control
Device: B Braun HNS 12 nerve stimulator
Registration Number
NCT06566664
Lead Sponsor
Stanford University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
82
Inclusion Criteria
  • Undergoing elective upper limb surgery with a planned brachial plexus nerve block
Exclusion Criteria
  • 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
  • Unable to consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ultrasound-guided brachial plexus block without peripheral nerve stimulationB Braun HNS 12 nerve stimulator sham controlPatients will receive the single shot brachial plexus block in the same way the first arm would, and the B Braun nerve stimulator will be placed in the same way, but not turned on.
Ultrasound-guided brachial plexus block with peripheral nerve stimulationB Braun HNS 12 nerve stimulatorPatients will receive a single shot brachial plexus block with ultrasound guidance as per standard of care, with additional use of the B. Braun HNS 12 nerve stimulator for duration of block placement.
Primary Outcome Measures
NameTimeMethod
Onset of sensory blockWithin 1 hour after the block placement

Determining time when patient feels numb

Secondary Outcome Measures
NameTimeMethod
Time to first analgesic requestUp to 1 year

Time it takes for patients to request for one supplemental analgesic medication

Onset of motor blockWithin 1 hour after the block placement

Determining time when patient cannot move

Patient satisfactionUp to 1 year

Assessing patient's satisfaction with the nerve block in controlling pain, using the short standard patient satisfaction Likert Scale, investigating pain management, comfort during procedure, explanations and communication level, and overall satisfaction with for each category a 5 point scale ranging from "strongly disagree" to "strongly agree".

Duration of sensory/motor block1 day

Time until the patient feels his limb again and can move

Trial Locations

Locations (1)

Stanford University Hospital

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Stanford, California, United States

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