Peripheral Neurostimulation for Nerve Block Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B Braun HNS 12 nerve stimulator, B Braun HNS 12 nerve stimulator sham control.
- Who it may be relevant to
- Registry conditions: Pain Syndrome, Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device B Braun HNS 12 nerve stimulator
Nerve stimulator that is traditionally used for nerve localization during block placements. - Device B Braun HNS 12 nerve stimulator sham control
Stimulator will be placed and turned on, but the grounding electrode will not be connected to prevent nerve stimulation.
Primary outcome measures
- Onset of sensory block [Time frame: Within 1 hour after the block placement]
Secondary outcome measures (12)
- Onset of motor block [Time frame: Within 1 hour after the block placement]
- Duration of sensory block [Time frame: up to 7 days after surgery]
- duration of motor block [Time frame: up to 7 days after surgery]
- When patient experience first pain [Time frame: up to day 7 post operatively]
- Time of first opioid taken [Time frame: within the first 7 days after surgery]
- Opioid usage at day 1 [Time frame: at post operative day 1]
- opioid usage assessment at day 7 [Time frame: Within the Post operative day 1 and 7]
- Opioid usage assessment at day 28 [Time frame: usage between post operative day 7 and 28]
- Last opioid usage after day 28 [Time frame: Assessment within 1 year]
- Amount of opioid usage after 28 days [Time frame: 28 days to 1 year after surgery]
- Patient satisfaction [Time frame: At Post Operative day 7, 28 and 1 year]
- General satisfaction [Time frame: at post operative day 7, 28 and 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Stanford University Hospital — Stanford
Identifiers
NCT: NCT06566664 · 76523