Peripheral Neurostimulation
Pain Syndrome · Pain Management
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 150 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Onset of Motor Block
Plazo: 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
Plazo: 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.
Medidas secundarias
Skin Temperature Change
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: 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
Plazo: After surgery, up until catheter discontinuation.
Patients' catheter duration before discontinuation, as measured by Avoset pump device data.
Total Local Anesthetic Use with Catheter
Plazo: After surgery, up until catheter discontinuation.
Patients' local anesthetic use with catheter, as measured by Avoset pump device data.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Stanford University HospitalStanford, California, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Stanford University
- Inicio del estudio
- 23 jul 2025 Real
- Finalización primaria
- 30 jul 2027 Estimado
- Finalización del estudio
- 30 jul 2027 Estimado
- Primera publicación
- 22 ago 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Peripheral Neurostimulation
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026