Peripheral Neurostimulation for Nerve Block Placement

NCT ID: NCT06566664

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-21
• Study Completion Date: 2026-06-30

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.

Conditions

Pain Syndrome; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

B Braun HNS 12 nerve stimulator

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

B Braun HNS 12 nerve stimulator sham control

Intervention Type: DEVICE

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

Interventions

B Braun HNS 12 nerve stimulator

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Louis Horn

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Hospital

Stanford, California, United States

Countries

United States

Central Contacts

Jean-Louis Horn, MD

Role: CONTACT

hornj@stanford.edu

(503) 381-1645

Ksenia Kasimova, MD

Role: CONTACT

kasimova@stanford.edu

6507889458

Facility Contacts

Jean-Louis Horn, MD

Role: primary

Other Identifiers

76523

Identifier Type: -

Identifier Source: org_study_id