Erector Spinae Plane Block
Conditions
Brief summary
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.
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.
Interventions
DRUGBupivacaine (erector spinae plane block)
Ultrasound-guided erector spinae plane block (ESPB) performed with injection of bupivacaine, administered in place of standard systemic pain medication.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | 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. |
| Total Emergency Department Length of Stay | From Emergency Department arrival to disposition, up to 24 hours | Total time in hours from Emergency Department (ED) arrival to ED disposition. |
| Time Required to Perform the Erector Spinae Plane Block (ESPB) | 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). |
| Number of Participants With Pneumothorax | Through Emergency Department stay, up to 24 hours | Number of participants with pneumothorax identified as a complication of the erector spinae plane block (ESPB). |
| Number of Participants With Local Anesthetic Systemic Toxicity (LAST) | 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. |
| Number of Participants With Opioid-Related Adverse Events | Through Emergency Department stay, up to 24 hours | Number of participants experiencing an adverse event attributed to systemic opioid analgesia. |
Countries
United States
Contacts
CONTACTMegan E Guy, MD
Outcome results
None listed