- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826936
Nerve Block for Severe Abdominal Pain in the Emergency Department (ESPB)
September 16, 2026 updated by: 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 12, 2026
First Submitted That Met QC Criteria
September 16, 2026
First Posted (Actual)
September 17, 2026
Study Record Updates
Last Update Posted (Actual)
September 17, 2026
Last Update Submitted That Met QC Criteria
September 16, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2529 (Saudi food and drug authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators do not plan to share individual participant data (IPD).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.