ClinicalTrials.gg
Enrolling by invitationNCT06566664Updated Nov 10, 2026

Peripheral Neurostimulation

An interventional study of B Braun HNS 12 nerve stimulator and B Braun HNS 12 nerve stimulator sham control in Pain Syndrome and Pain Management, sponsored by Stanford University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Primary outcomes revisedTitle changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 allows for 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.

02

Conditions studied

  • Pain Syndrome
  • Pain Management

Keywords

  • peripheral nerve block
  • neurostimulation
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old
  • above III
  • Chronic pain condition with daily milligrams of morphine equivalent > 30
  • Poorly controlled psychiatric condition
  • Coagulopathy
  • Active infection
  • Moderate, severe or progressing neuropathy
  • /Chronic oxygen user
  • Pregnancy
  • Incarceration
  • Unable to consent
  • > 35
  • Pacemaker
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceB Braun HNS 12 nerve stimulator

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

  • DeviceB 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.

06

What researchers measure

Primary outcomes

  1. Onset of Motor Block

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

    Time frame: Within 1 hour after the block placement.

  2. Onset of Sensory Block

    Determining time when patient experiences first symptoms of local anesthetic action on the superior trunk distribution over the shoulder.

    Time frame: Within 1 hour after the block placement.

Secondary outcomes

  1. Skin Temperature Change

    Measuring changes in skin temperature over the course of pre and post stimulation and nerve blocking between the blocked and unblocked arms, measured in degrees Celsius. Using Medline Temperature Sensor.

    Time frame: Immediately before and up to 1 hour after neurostimulation and nerve block is performed.

  2. When Patient Experiences First Pain

    Time after surgery at which the patient experiences first sign of pain at the surgical site, as measured by the time for first local anesthetic bolus based on pump device history.

    Time frame: up to day 7 post operatively

  3. Time of First Opioid Taken

    As measured by asking patients if they were taking opioids daily after surgery, up to one week.

    Time frame: Within the first 7 days after surgery

  4. Total Post Operative MME/Opioid Usage at Day 1

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 1

  5. Total Post Operative MME/Opioid Usage at Day 2

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 2

  6. Total Post Operative MME Opioid Usage at Day 3

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 3

  7. Total Post Operative MME Opioid Usage at Day 4

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 4

  8. Total Post Operative MME Opioid Usage at Day 5

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 5

  9. Total Post Operative MME Opioid Usage at Day 6

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 6

  10. Opioid Usage Assessment at Day 7

    Milligram of morphine equivalent, measured by asking patients for amount of pills taken in the last 24 hours (and chart knowledge of prescription mg).

    Time frame: On Post Operative Day 7

  11. Opioid Usage Assessment at Day 28

    Milligram of morphine equivalent, measured by asking patients 1) if patients took opioids within the last 3 weeks and 2) if so, how many pills per day.

    Time frame: On Post Operative Day 28

  12. Opioid Usage Assessment at 6 Months

    Milligram of morphine equivalent, measured by asking patients 1) if patients took opioids within the last 5 months and 2) if so, how many pills per day.

    Time frame: On Post Operative Month 6

  13. Opioid Usage Assessment at 1 Year

    Milligram of morphine equivalent, measured by asking patients 1) if patients took opioids within the last 6 months and 2) if so, how many pills per day.

    Time frame: On Post Operative 1 Year

  14. Quality of Recovery

    Using the standardized -Quality of Recovery 15- at post operative days 7 and 28, 6 months, and 1 year. Each item count on a 0-10 scale where 0 is worst 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

    Time frame: At Post Operative days 7 and 28 , 6 months, and 1 year

  15. General satisfaction

    General satisfaction on a scale from 1-5 (extremely unsatisfied, unsatisfied, neutral, satisfy, extremely satisfied). Asking patients if they would receive the block again (Y/N).

    Time frame: At post operative days 0, 1, 7, 28, 6 months, and 1 year

  16. Adverse Events

    Numbness, Weakness, Tingling, Breathing Difficulties, Hoarseness

    Time frame: Asked to patients (Check all that apply) at Post Operative Day 0, 1, 7, 28, 6 Months, and 1 Year. Patients have the opportunity to specify in detail for each sympom they select.

  17. Catheter Duration Before Discontinuation

    Patients' catheter duration before discontinuation, as measured by Avoset pump device data.

    Time frame: After surgery, up until catheter discontinuation.

  18. Total Local Anesthetic Use with Catheter

    Patients' local anesthetic use with catheter, as measured by Avoset pump device data.

    Time frame: After surgery, up until catheter discontinuation.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 edited, 1 added
What changed in the outcomes
  • EditedOnset of sensory and motor blockMotor BlockTime frame: Within 1 hour after the block placement → Within 1 hour after the block placement.
  • AddedOnset of Sensory BlockTime frame: Within 1 hour after the block placement.
Nov 10, 2026
Secondary outcomes
6 edited, 1 time frame changed, 11 added, 5 removed, 1 description edited
What changed in the outcomes
  • EditedWhen patient experience first painPatient Experiences First PainTime frame: up to day 7 post operatively
  • EditedTime of first opioid takenFirst Opioid TakenTime frame: within the first 7 days after surgery → Within the first 7 days after surgery
  • EditedTotal Post Operative MME/Opioid usageUsage at dayDay 1Time frame: at post operative day 1 → On Post Operative Day 1
  • Editedopioid usage assessmentTotal Post Operative MME/Opioid Usage at day 7Day 2Time frame: Within the Post operative day 1 and 7 → On Post Operative Day 2
  • EditedTotal Post Operative MME Opioid usage assessmentUsage at day 28Day 3Time frame: usage between post operative day 7 and 28 → On Post Operative Day 3
  • EditedLast opioid usage after day 28Opioid Usage Assessment at Day 7Time frame: Assessment within 1 year → On Post Operative Day 7
  • AddedSkin Temperature ChangeTime frame: Immediately before and up to 1 hour after neurostimulation and nerve block is performed.
  • AddedTotal Post Operative MME Opioid Usage at Day 4Time frame: On Post Operative Day 4
  • AddedTotal Post Operative MME Opioid Usage at Day 5Time frame: On Post Operative Day 5
  • AddedTotal Post Operative MME Opioid Usage at Day 6Time frame: On Post Operative Day 6
  • AddedOpioid Usage Assessment at Day 28Time frame: On Post Operative Day 28
  • AddedOpioid Usage Assessment at 6 MonthsTime frame: On Post Operative Month 6
  • AddedOpioid Usage Assessment at 1 YearTime frame: On Post Operative 1 Year
  • AddedQuality of RecoveryTime frame: At Post Operative days 7 and 28 , 6 months, and 1 year
  • AddedAdverse EventsTime frame: Asked to patients (Check all that apply) at Post Operative Day 0, 1, 7, 28, 6 Months, and 1 Year. Patients have the opportunity to specify in detail for each sympom they select.
  • AddedCatheter Duration Before DiscontinuationTime frame: After surgery, up until catheter discontinuation.
  • AddedTotal Local Anesthetic Use with CatheterTime frame: After surgery, up until catheter discontinuation.
  • RemovedOnset of motor blockTime frame: Within 1 hour after the block placement
  • RemovedDuration of sensory blockTime frame: up to 7 days after surgery
  • Removedduration of motor blockTime frame: up to 7 days after surgery
  • RemovedAmount of opioid usage after 28 daysTime frame: 28 days to 1 year after surgery
  • RemovedPatient satisfactionTime frame: At Post Operative day 7, 28 and 1 year
  • Time frameGeneral satisfactionat post operative day 7, 28 and 1 year → At post operative days 0, 1, 7, 28, 6 months, and 1 year
  • DescriptionGeneral satisfaction: how it is measured was reworded
Nov 10, 2026
Title
Peripheral Neurostimulation for Nerve Block Placement
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary outcomes 1 edited, 1 added
    What changed in the outcomes
    • EditedOnset of sensory and motor blockMotor BlockTime frame: Within 1 hour after the block placement → Within 1 hour after the block placement.
    • AddedOnset of Sensory BlockTime frame: Within 1 hour after the block placement.
    Secondary outcomes 6 edited, 1 time frame changed, 11 added, 5 removed, 1 description edited
    What changed in the outcomes
    • EditedWhen patient experience first painPatient Experiences First PainTime frame: up to day 7 post operatively
    • EditedTime of first opioid takenFirst Opioid TakenTime frame: within the first 7 days after surgery → Within the first 7 days after surgery
    • EditedTotal Post Operative MME/Opioid usageUsage at dayDay 1Time frame: at post operative day 1 → On Post Operative Day 1
    • Editedopioid usage assessmentTotal Post Operative MME/Opioid Usage at day 7Day 2Time frame: Within the Post operative day 1 and 7 → On Post Operative Day 2
    • EditedTotal Post Operative MME Opioid usage assessmentUsage at day 28Day 3Time frame: usage between post operative day 7 and 28 → On Post Operative Day 3
    • EditedLast opioid usage after day 28Opioid Usage Assessment at Day 7Time frame: Assessment within 1 year → On Post Operative Day 7
    • AddedSkin Temperature ChangeTime frame: Immediately before and up to 1 hour after neurostimulation and nerve block is performed.
    • AddedTotal Post Operative MME Opioid Usage at Day 4Time frame: On Post Operative Day 4
    • AddedTotal Post Operative MME Opioid Usage at Day 5Time frame: On Post Operative Day 5
    • AddedTotal Post Operative MME Opioid Usage at Day 6Time frame: On Post Operative Day 6
    • AddedOpioid Usage Assessment at Day 28Time frame: On Post Operative Day 28
    • AddedOpioid Usage Assessment at 6 MonthsTime frame: On Post Operative Month 6
    • AddedOpioid Usage Assessment at 1 YearTime frame: On Post Operative 1 Year
    • AddedQuality of RecoveryTime frame: At Post Operative days 7 and 28 , 6 months, and 1 year
    • AddedAdverse EventsTime frame: Asked to patients (Check all that apply) at Post Operative Day 0, 1, 7, 28, 6 Months, and 1 Year. Patients have the opportunity to specify in detail for each sympom they select.
    • AddedCatheter Duration Before DiscontinuationTime frame: After surgery, up until catheter discontinuation.
    • AddedTotal Local Anesthetic Use with CatheterTime frame: After surgery, up until catheter discontinuation.
    • RemovedOnset of motor blockTime frame: Within 1 hour after the block placement
    • RemovedDuration of sensory blockTime frame: up to 7 days after surgery
    • Removedduration of motor blockTime frame: up to 7 days after surgery
    • RemovedAmount of opioid usage after 28 daysTime frame: 28 days to 1 year after surgery
    • RemovedPatient satisfactionTime frame: At Post Operative day 7, 28 and 1 year
    • Time frameGeneral satisfactionat post operative day 7, 28 and 1 year → At post operative days 0, 1, 7, 28, 6 months, and 1 year
    • DescriptionGeneral satisfaction: how it is measured was reworded
    Title Peripheral Neurostimulation for Nerve Block Placement
    + 3 other changes: verification date, description and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06566664
Responsible party
Jean-Louis Horn (Professor of Anesthesiology, Stanford University) — Principal investigator
First posted
Aug 22, 2024
Start date
Jul 23, 2025
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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