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Nerve Block for Severe Abdominal Pain in the Emergency Department (ESPB)

16. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Megan E Guy, MD
  • Telefonnummer: 805-295-9404
  • E-post: guym@hs.uci.edu

Studiesteder

  • Forente stater
    • California
      • Orange, California, Forente stater, 92868
        • Rekruttering
        • UC Irvine, Department of Emergency Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Bupivacaine (erector spinae plane block)
Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.
Ingen inngripen: Standard Systemic Pain Medication
Patients receive standard-of-care systemic pain medication (non-opioid analgesics or opioids such as Norco/hydrocodone-acetaminophen).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pain Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Satisfaction Score
Tidsramme: 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.
Prior to Emergency Department discharge, up to 24 hours
Total Emergency Department Length of Stay
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Number of Participants With Local Anesthetic Systemic Toxicity (LAST)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Irvine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. oktober 2024

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

16. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2529 (Saudi food and drug authority)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The investigators do not plan to share individual participant data (IPD).

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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