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By invitationNCT06566664ClinicalTrials.gov record

Peripheral Neurostimulation

Pain Syndrome · Pain Management

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
150 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 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 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
  • BMI \> 35
  • Pacemaker
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Double masked
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

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

B Braun HNS 12 nerve stimulator DEVICE

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

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Onset of Motor Block

Time frame: Within 1 hour after the block placement.

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

Onset of Sensory Block

Time frame: Within 1 hour after the block placement.

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

Secondary measures

Skin Temperature Change

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

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.

When Patient Experiences First Pain

Time frame: up to day 7 post operatively

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 of First Opioid Taken

Time frame: Within the first 7 days after surgery

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

Total Post Operative MME/Opioid Usage at Day 1

Time frame: On Post Operative 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).

Total Post Operative MME/Opioid Usage at Day 2

Time frame: On Post Operative 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).

Total Post Operative MME Opioid Usage at Day 3

Time frame: On Post Operative 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).

Total Post Operative MME Opioid Usage at Day 4

Time frame: On Post Operative 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).

Total Post Operative MME Opioid Usage at Day 5

Time frame: On Post Operative 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).

Total Post Operative MME Opioid Usage at Day 6

Time frame: On Post Operative 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).

Opioid Usage Assessment at Day 7

Time frame: On Post Operative 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).

Opioid Usage Assessment at Day 28

Time frame: On Post Operative 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.

Opioid Usage Assessment at 6 Months

Time frame: On Post Operative Month 6

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.

Opioid Usage Assessment at 1 Year

Time frame: On Post Operative 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.

Quality of Recovery

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

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

General satisfaction

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

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).

Adverse Events

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.

Numbness, Weakness, Tingling, Breathing Difficulties, Hoarseness

Catheter Duration Before Discontinuation

Time frame: After surgery, up until catheter discontinuation.

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

Total Local Anesthetic Use with Catheter

Time frame: After surgery, up until catheter discontinuation.

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Stanford University HospitalStanford, California, United StatesStatus unknown

Study team and timeline

Lead sponsor
Stanford University
Study start
Jul 23, 2025 Actual
Primary completion
Jul 30, 2027 Estimated
Study completion
Jul 30, 2027 Estimated
First posted
Aug 22, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Peripheral Neurostimulation

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026