Peripheral Neurostimulation for Nerve Block Placement

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain Management; Pain Syndrome
• Intervention / Treatment: Device: B Braun HNS 12 nerve stimulator; Device: B Braun HNS 12 nerve stimulator sham control

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: B Braun HNS 12 nerve stimulator; Nerve stimulator that is traditionally used for nerve localization during block placements.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of motor block	Determining time when patient start loosing strength at the musculo cutaneous nerve (biceps brichialis muscle)	Within 1 hour after the block placement
Duration of sensory block	Time after surgery at which the patient recovers first sign of sensory function	up to 7 days after surgery
duration of motor block	Time after surgery at which the patient recovers a biceps brachialis function	up to 7 days after surgery
When patient experience first pain	Time after surgery at which the patient experience first sign of pain at the surgical site	up to day 7 post operatively
Time of first opioid taken	When the first opioid was taken	within the first 7 days after surgery
Opioid usage at day 1	Milligram of morphine equivalent	at post operative day 1
opioid usage assessment at day 7	Milligram of morphine equivalent taken	Within the Post operative day 1 and 7
Opioid usage assessment at day 28	milligram of morphine equivalent assess at day 28	usage between post operative day 7 and 28
Last opioid usage after day 28	When was the last day of opioid usage	Assessment within 1 year
Amount of opioid usage after 28 days	Milligram of morphine equivalent use weekly after 28 days	28 days to 1 year after surgery
Patient satisfaction	Assessing patient's satisfaction, using the standardized -Quality of Recovery 15- at post operative day 7, 28 and 1 year. Each item count on a 0-10 scale where O is worse and 10 is best PART A How have you been feeling in the last 24 hours? (0 to 10, where 0 = none of the time [poor] and 10 = all of the time [excellent] Q.1 Able to breathe easily Q.2 Been able to enjoy food Q.3 Feeling rested Q.4 Have had a good sleep Q.5 Able to look after personal toilet and hygiene unaided Q.6 Able to communicate with family or friends Q.7 Getting support from hospital doctors and nurses Q.8 Able to return to work or usual home activities Q.9 Feeling comfortable and in control Q.10 Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where 10 = none of the time [excellent] and 0 = all of the time [poor]) Q.11 Moderate pain Q.12 Severe pain Q.13 Nausea or vomiting Q.14 Feeling worried or anxious Q.15 Feeling sad or depressed	At Post Operative day 7, 28 and 1 year
General satisfaction	General satisfaction on a scale from 1-5 (extremely unsatisfied, unsatisfied, neutral, satisfy, extremely satisfied)	at post operative day 7, 28 and 1 year

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: neurostimulation; peripheral nerve block
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Somatoform Disorders; Agnosia
• Other Study ID Numbers: 76523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No