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Enrolling by Invitation

NCT Number: NCT06566664

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.

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Key information

Conditions

Pain Syndrome Agnosia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Onset of sensory 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)

Secondary outcomes

  1. Onset of motor block

    Time frame: Within 1 hour after the block placement

    Determining time when patient start loosing strength at the musculo cutaneous nerve (biceps brichialis muscle)

  2. Duration of sensory block

    Time frame: up to 7 days after surgery

    Time after surgery at which the patient recovers first sign of sensory function

  3. duration of motor block

    Time frame: up to 7 days after surgery

    Time after surgery at which the patient recovers a biceps brachialis function

  4. When patient experience first pain

    Time frame: up to day 7 post operatively

    Time after surgery at which the patient experience first sign of pain at the surgical site

  5. Time of first opioid taken

    Time frame: within the first 7 days after surgery

    When the first opioid was taken

  6. Opioid usage at day 1

    Time frame: at post operative day 1

    Milligram of morphine equivalent

  7. opioid usage assessment at day 7

    Time frame: Within the Post operative day 1 and 7

    Milligram of morphine equivalent taken

  8. Opioid usage assessment at day 28

    Time frame: usage between post operative day 7 and 28

    milligram of morphine equivalent assess at day 28

  9. Last opioid usage after day 28

    Time frame: Assessment within 1 year

    When was the last day of opioid usage

  10. Amount of opioid usage after 28 days

    Time frame: 28 days to 1 year after surgery

    Milligram of morphine equivalent use weekly after 28 days

  11. Patient satisfaction

    Time frame: At Post Operative day 7, 28 and 1 year

    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

  12. General satisfaction

    Time frame: at post operative day 7, 28 and 1 year

    General satisfaction on a scale from 1-5 (extremely unsatisfied, unsatisfied, neutral, satisfy, extremely satisfied)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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