Pain SyndromeNCT06566664
Peripheral Neurostimulation for Nerve Block Placement
A study testing B Braun HNS 12 nerve stimulator in people with Pain Syndrome and Pain Management, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Syndrome, Pain Management
- What is being tested?
- B Braun HNS 12 nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective upper limb surgery with a planned brachial plexus nerve block
Who cannot join
- 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
Show all 13Show fewer
- Moderate, severe or progressing neuropathy
- COPD/Chronic oxygen user
- Pregnancy
- Incarceration
- Unable to consent
- BMI > 35
- Pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University Hospital
Stanford, California, 94305
About this study
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 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
- Being tested
- B Braun HNS 12 nerve stimulator, B Braun HNS 12 nerve stimulator sham control
- Keywords
- peripheral nerve block, neurostimulation
- Medical subject headings
- Somatoform Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B Braun HNS 12 nerve stimulatorDevice
Nerve stimulator that is traditionally used for nerve localization during block placements.
B Braun HNS 12 nerve stimulator sham controlDevice
Stimulator will be placed and turned on, but the grounding electrode will not be connected to prevent nerve stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: B Braun HNS 12 nerve stimulator sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of sensory and motor block
Determining time when patient experience first symptoms of local anesthetic action on the upper trunk distribution (median or musculo cutaneous nerve)
Measured: Within 1 hour after the block placement
Secondary outcomes (12)
Onset of motor block
Determining time when patient start loosing strength at the musculo cutaneous nerve (biceps brichialis muscle)
Measured: Within 1 hour after the block placement
Duration of sensory block
Time after surgery at which the patient recovers first sign of sensory function
Measured: up to 7 days after surgery
duration of motor block
Time after surgery at which the patient recovers a biceps brachialis function
Measured: 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
Measured: up to day 7 post operatively
Time of first opioid taken
When the first opioid was taken
Measured: within the first 7 days after surgery
Opioid usage at day 1
Milligram of morphine equivalent
Measured: at post operative day 1
opioid usage assessment at day 7
Milligram of morphine equivalent taken
Measured: Within the Post operative day 1 and 7
Opioid usage assessment at day 28
milligram of morphine equivalent assess at day 28
Measured: usage between post operative day 7 and 28
Last opioid usage after day 28
When was the last day of opioid usage
Measured: Assessment within 1 year
Amount of opioid usage after 28 days
Milligram of morphine equivalent use weekly after 28 days
Measured: 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
Measured: 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)
Measured: at post operative day 7, 28 and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start23 Jul 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566664
- Sponsor's protocol ID
- 76523
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Neurostimulation for Nerve Block Placement
- ClinicalTrials.gov ID
- NCT06566664
- Acronym / sponsor ID
- 76523
- Conditions
- Pain Syndrome, Pain Management
- Keywords
- peripheral nerve block, neurostimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided brachial plexus block with peripheral nerve stimulation | Experimental | Device: B Braun HNS 12 nerve stimulatorPatients 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. |
| Ultrasound-guided brachial plexus block without peripheral nerve stimulation | Sham comparator | Device: B Braun HNS 12 nerve stimulator sham controlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective upper limb surgery with a planned brachial plexus nerve block
Key exclusion criteria (13 listed)
- Under 18 years old
- ASA score above III
- Chronic pain condition with daily milligrams of morphine equivalent > 30
- Poorly controlled psychiatric condition
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B Braun HNS 12 nerve stimulatorNerve stimulator that is traditionally used for nerve localization during block placements. | Device | Ultrasound-guided brachial plexus block with peripheral nerve stimulation |
| B Braun HNS 12 nerve stimulator sham controlStimulator will be placed and turned on, but the grounding electrode will not be connected to prevent nerve stimulation. | Device | Ultrasound-guided brachial plexus block without peripheral nerve stimulation |
Primary outcome
Onset of sensory and motor block
Time frame: Within 1 hour after the block placement
Determining time when patient experience first symptoms of local anesthetic action on the upper trunk distribution (median or musculo cutaneous nerve)
12 secondary outcomes
Onset of motor block
Time frame: Within 1 hour after the block placement
Duration of sensory block
Time frame: up to 7 days after surgery
duration of motor block
Time frame: up to 7 days after surgery
When patient experience first pain
Time frame: up to day 7 post operatively
Time of first opioid taken
Time frame: within the first 7 days after surgery
Opioid usage at day 1
Time frame: at post operative day 1
opioid usage assessment at day 7
Time frame: Within the Post operative day 1 and 7
Opioid usage assessment at day 28
Time frame: usage between post operative day 7 and 28
Last opioid usage after day 28
Time frame: Assessment within 1 year
Amount of opioid usage after 28 days
Time frame: 28 days to 1 year after surgery
Patient satisfaction
Time frame: At Post Operative day 7, 28 and 1 year
General satisfaction
Time frame: at post operative day 7, 28 and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B Braun HNS 12 nerve stimulator in people with Pain Syndrome and Pain Management, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of sensory and motor block (time frame: Within 1 hour after the block placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.