Peripheral Neurostimulation for Nerve Block Placement

NCT06566664 | Enrolling By Invitation FDA Device

• 1 other identifier: 76523
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Syndrome; Pain Management

Keywords

peripheral nerve block; neurostimulation

Outcome Measures

Primary Outcomes (1)

• Onset of sensory block

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

  Within 1 hour after the block placement

Secondary Outcomes (12)

• 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

Study Arms (2)

Ultrasound-guided brachial plexus block with peripheral nerve stimulation

EXPERIMENTAL

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.

Device: B Braun HNS 12 nerve stimulator

Ultrasound-guided brachial plexus block without peripheral nerve stimulation

SHAM COMPARATOR

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.

Device: B Braun HNS 12 nerve stimulator sham control

Interventions

B Braun HNS 12 nerve stimulator DEVICE

Nerve stimulator that is traditionally used for nerve localization during block placements.

Ultrasound-guided brachial plexus block with peripheral nerve stimulation

B Braun HNS 12 nerve stimulator sham control DEVICE

Stimulator will be placed and turned on, but the grounding electrode will not be connected to prevent nerve stimulation.

Ultrasound-guided brachial plexus block without peripheral nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Somatoform Disorders; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 22, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)