Nerve Block for Severe Abdominal Pain in the Emergency Department

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine (erector spinae plane block)

    Drug

    Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Erector Spinae Plane Block (ESPB)Experimental treatment 1 intervention
Group B: Standard Systemic Pain MedicationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Pain Score

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.

Time frame
Baseline (time of consent), 30 minutes post-intervention, and 3 hours post-intervention

Secondary outcomes

1

Patient Satisfaction Score

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.

Time frame
Prior to Emergency Department discharge, up to 24 hours
2

Total Emergency Department Length of Stay

Total time in hours from Emergency Department (ED) arrival to ED disposition.

Time frame
From Emergency Department arrival to disposition, up to 24 hours
3

Time Required to Perform the Erector Spinae Plane Block (ESPB)

Time in minutes required to complete the ultrasound-guided erector spinae plane block (ESPB) procedure, reported by operator training level (resident, fellow, or attending).

Time frame
At the time of the procedure, up to 3 hours
4

Number of Participants With Pneumothorax

Number of participants with pneumothorax identified as a complication of the erector spinae plane block (ESPB).

Time frame
Through Emergency Department stay, up to 24 hours

Other outcomes

Sponsors and contacts

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