Peripheral Neurostimulation for Nerve Block Placement

Stanford University

Status: Invitation-only

Conditions: Pain Syndrome; Pain Management

Treatments: Device: B Braun HNS 12 nerve stimulator sham control; Device: B Braun HNS 12 nerve stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT06566664

76523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups

Ultrasound-guided brachial plexus block with peripheral nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: B Braun HNS 12 nerve stimulator

Ultrasound-guided brachial plexus block without peripheral nerve stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: B Braun HNS 12 nerve stimulator sham control