- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07826936
Nerve Block for Severe Abdominal Pain in the Emergency Department (ESPB)
16 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Prima fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Megan E Guy, MD
- Numero di telefono: 805-295-9404
- Email: guym@hs.uci.edu
Luoghi di studio
-
-
California
-
Orange, California, Stati Uniti, 92868
- Reclutamento
- UC Irvine, Department of Emergency Medicine
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.
|
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Nessun intervento: Standard Systemic Pain Medication
Patients receive standard-of-care systemic pain medication (non-opioid analgesics or opioids such as Norco/hydrocodone-acetaminophen).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Pain Score
Lasso di tempo: Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention
|
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.
|
Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient Satisfaction Score
Lasso di tempo: Prior to Emergency Department discharge, up to 24 hours
|
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
|
|
Total Emergency Department Length of Stay
Lasso di tempo: From Emergency Department arrival to disposition, up to 24 hours
|
Total time in hours from Emergency Department (ED) arrival to ED disposition.
|
From Emergency Department arrival to disposition, up to 24 hours
|
|
Time Required to Perform the Erector Spinae Plane Block (ESPB)
Lasso di tempo: At the time of the procedure, up to 3 hours
|
Time in minutes required to complete the ultrasound-guided erector spinae plane block (ESPB) procedure, reported by operator training level (resident, fellow, or attending).
|
At the time of the procedure, up to 3 hours
|
|
Number of Participants With Pneumothorax
Lasso di tempo: Through Emergency Department stay, up to 24 hours
|
Number of participants with pneumothorax identified as a complication of the erector spinae plane block (ESPB).
|
Through Emergency Department stay, up to 24 hours
|
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Number of Participants With Local Anesthetic Systemic Toxicity (LAST)
Lasso di tempo: Through Emergency Department stay, up to 24 hours
|
Number of participants meeting clinical criteria for Local Anesthetic Systemic Toxicity (LAST), including cardiac dysrhythmia or seizure.
|
Through Emergency Department stay, up to 24 hours
|
|
Number of Participants With Opioid-Related Adverse Events
Lasso di tempo: Through Emergency Department stay, up to 24 hours
|
Number of participants experiencing an adverse event attributed to systemic opioid analgesia.
|
Through Emergency Department stay, up to 24 hours
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 ottobre 2024
Completamento primario (Stimato)
1 dicembre 2027
Completamento dello studio (Stimato)
1 dicembre 2027
Date di iscrizione allo studio
Primo inviato
12 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 settembre 2026
Primo Inserito (Effettivo)
17 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2529 (Saudi food and drug authority)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
The investigators do not plan to share individual participant data (IPD).
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .