Nerve Block for Severe Abdominal Pain in the Emergency Department (ESPB)
16 de septiembre de 2026 actualizado por: Megan Guy, University of California, Irvine
Erector Spinae Plane Block for Patients With Intractable Abdominal Pain in the Emergency Department: A Pilot Study
Currently, the standard treatment of nonsurgical abdominal pain in the Emergency Department (ED) includes narcotic pain medication.
This can be addictive and contributes to the current opioid epidemic.
Recent studies have shown that the Erector Spinae Plane Block (ESPB) is an alternative approach to achieving abdominal analgesia without the use of any systemic pain medications.
It is a regional nerve block that can be used by emergency medicine physicians by injecting anesthetic into the erector spinae plane under ultrasound guidance, which effectively anesthetizes the abdomen.
This procedure is within the scope of practice of Emergency Medicine residents, fellows, and attendings who have received training in Point-of-Care Ultrasound (POCUS) and who have also received specialized training on how to perform the ESPB under ultrasound guidance.
Adult patients will be screened for intractable abdominal pain (persistent pain despite systemic pain medications) and eligibility to receive the nerve block (for example, patients cannot be pregnant, must be able to verbalize pain and satisfaction scores, and must have no contraindication to receiving the nerve block).
In this study, the investigators will perform a small pilot study to determine how effective the ESPB is compared to systemic pain medications, and how easy or difficult it is to perform the ESPB in the Emergency Department as a means of controlling abdominal pain.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This study takes an effectiveness-implementation Hybrid Type 2 trial design with a dual purpose: (i) to examine the effectiveness of the Erector Spinae Plane Block (ESPB) compared to standard systemic pain medication in patients with intractable, nonsurgical abdominal pain in the Emergency Department (ED); and (ii) to qualitatively analyze the feasibility of implementing the ESPB in the Emergency Department as a means of controlling abdominal pain.
The investigators hypothesize that patients with intractable, nonsurgical abdominal pain who receive the ESPB will have non-inferior pain scores compared to patients who receive systemic pain medications.
The investigators further hypothesize that patients who receive the ESPB will require fewer Morphine Milligram Equivalents (MME) to achieve abdominal pain control than patients who do not receive the ESPB.
The investigators aim to identify potential challenges that could affect the feasibility of implementing the ESPB in the Emergency Department setting, such as time constraints, lack of provider willingness to perform the block, lack of patient willingness to receive the block, and difficulty finding the appropriate supplies.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Megan E Guy, MD
- Número de teléfono: 805-295-9404
- Correo electrónico: guym@hs.uci.edu
Ubicaciones de estudio
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California
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Orange, California, Estados Unidos, 92868
- Reclutamiento
- UC Irvine, Department of Emergency Medicine
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Over 18 years of age
- Abdominal pain that is intractable, defined as pain persisting despite administration of more than one dose of narcotic medication
- Nonsurgical abdominal pain, determined by either a benign abdominal exam not warranting a computed tomography (CT) scan, or a CT scan showing no identifiable surgical process
- Patient may present from the Emergency Department (ED) or may be an admitted inpatient
Exclusion Criteria:
- Under 18 years of age
- Pregnant, confirmed by a positive pregnancy test sent on all female patients of childbearing age presenting with abdominal pain
- Psychiatric patients
- Unable to verbalize a pain score, or impaired decision-making capacity (e.g., obtunded, intoxicated, lethargic, critically ill, intubated, or cognitively impaired)
- Any contraindication to nerve blocks, such as infection overlying the injection site, a bleeding disorder, or an allergy to anesthetic
- Surgical abdomen requiring serial abdominal exams
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Erector Spinae Plane Block (ESPB)
Patients receive the erector spinae plane block (ESPB) via ultrasound-guided injection of bupivacaine, with systemic analgesics provided as needed if pain persists.
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Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.
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Sin intervención: Standard Systemic Pain Medication
Patients receive standard-of-care systemic pain medication (non-opioid analgesics or opioids such as Norco/hydrocodone-acetaminophen).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Pain Score
Periodo de tiempo: Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention
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Change from baseline in patient-reported pain intensity, measured on a standardized Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate greater pain.
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Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Satisfaction Score
Periodo de tiempo: Prior to Emergency Department discharge, up to 24 hours
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Patient-reported satisfaction with pain management, measured on a Numeric Rating Scale (NRS) ranging from 0 (not at all satisfied) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Prior to Emergency Department discharge, up to 24 hours
|
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Total Emergency Department Length of Stay
Periodo de tiempo: From Emergency Department arrival to disposition, up to 24 hours
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Total time in hours from Emergency Department (ED) arrival to ED disposition.
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From Emergency Department arrival to disposition, up to 24 hours
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Time Required to Perform the Erector Spinae Plane Block (ESPB)
Periodo de tiempo: At the time of the procedure, up to 3 hours
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Time in minutes required to complete the ultrasound-guided erector spinae plane block (ESPB) procedure, reported by operator training level (resident, fellow, or attending).
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At the time of the procedure, up to 3 hours
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Number of Participants With Pneumothorax
Periodo de tiempo: Through Emergency Department stay, up to 24 hours
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Number of participants with pneumothorax identified as a complication of the erector spinae plane block (ESPB).
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Through Emergency Department stay, up to 24 hours
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Number of Participants With Local Anesthetic Systemic Toxicity (LAST)
Periodo de tiempo: Through Emergency Department stay, up to 24 hours
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Number of participants meeting clinical criteria for Local Anesthetic Systemic Toxicity (LAST), including cardiac dysrhythmia or seizure.
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Through Emergency Department stay, up to 24 hours
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Number of Participants With Opioid-Related Adverse Events
Periodo de tiempo: Through Emergency Department stay, up to 24 hours
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Number of participants experiencing an adverse event attributed to systemic opioid analgesia.
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Through Emergency Department stay, up to 24 hours
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Abdelhamid, K., ElHawary, H., & Turner, J. P. (2020). The Use of the Erector Spinae Plane Block to Decrease Pain and Opioid Consumption in the Emergency Department: A Literature Review. Journal of Emergency Medicine, 58(4), 603-609. Ashworth, H., Sanders, N., Mantuani, D., & Nagdev, A. (2022). Ultrasound-Guided Erector Spinae Plane Block in Emergency Department for Abdominal Malignancy Pain: A Case Report. Clinical Practice and Cases in Emergency Medicine, 6(4), 315-318. Gopinath, B., Nayaka, R., Kuruvila, R., & Bhoi, S. (2022). Alleviating Refractory Abdominal Pain in Cholangiocarcinoma Using Erector Spinae Plane Block in the Emergency Department. Journal of Emergency Medicine, 62(3), 393-396. Intermite, C., Vetrugno, L., Pecori, D., Pizzolitto, S., & Bove, T. (2020). Erector spinae plane block for abdominal cancer pain: a case report of effective management. Minerva Anestesiologica, 86(12), 1354-1356. Chung, K., Choi, S. T., Jun, E. H., Choi, S. G., & Kim, E. D. (2021). Role of erector spinae plane block in controlling functional abdominal pain: Case reports. Medicine, 100(39), e27335. Das, S., Chatterjee, N., & Mitra, S. (2023). Managing acute pancreatitis pain with bilateral erector spinae plane catheters in a patient allergic to opioids and NSAIDS: A case report. Saudi Journal of Anaesthesia, 17(1), 87-90. Aréchiga-Ornelas, G. E., et al. (2022). Erector Spinae Plane Block in pediatric cancer pain: Case report. Colombian Journal of Anesthesiology, 50(2). Elkoundi, A., Eloukkal, Z., Bensghir, M., Belyamani, L., & Lalaoui, S. J. (2019). Erector spinae plane block for hyperalgesic acute pancreatitis. Pain Medicine, 20(5), 1055-1056. Allos, M. T., Zukowski, D. M., & Fidkowski, C. W. (2021). Erector Spinae Plane Continuous Catheters for Refractory Abdominal Pain Related to Necrotizing Pancreatitis: A Case Report. A&A Practice, 15(11), e01543. Mantuani, D., Josh Luftig, P. A., Herring, A., Mian, M., & Nagdev, A. (2020). Successful emergency pain control for acute panc
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de octubre de 2024
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2529 (Saudi food and drug authority)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The investigators do not plan to share individual participant data (IPD).
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .