Nerve Block for Severe Abdominal Pain in the Emergency Department (ESPB)
Erector Spinae Plane Block for Patients With Intractable Abdominal Pain in the Emergency Department: A Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Early Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Megan E Guy, MD
- Phone Number: 805-295-9404
- Email: guym@hs.uci.edu
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- UC Irvine, Department of Emergency Medicine
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.
|
|
No Intervention: Standard Systemic Pain Medication
Patients receive standard-of-care systemic pain medication (non-opioid analgesics or opioids such as Norco/hydrocodone-acetaminophen).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Score
Time Frame: 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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Score
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2529 (Saudi food and drug authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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