Clinical trial NCT06745453: Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
Official title: Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: erector spinae plane block
emergency department
low back pain
regional anesthesia
nerve block
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:

1. Does the ESPB reduce short-term pain in participants with low back pain?
2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?

Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.

Participants will:

Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days


Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.

Exclusion Criteria:

* Do not speak English or Spanish as a primary language
* Are incarcerated
* Have a known pregnancy
* Are allergic to amide-type local anesthetics
* Are unable to tolerate positioning for the procedure
* Have a critical illness precluding the ability to perform the procedure.

Primary outcomes:
measure: Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale
timeFrame: Change from baseline to 120 minutes post-intervention
Secondary outcomes:
measure: Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale
timeFrame: Change from baseline to 30 minutes post-intervention
measure: Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale
timeFrame: Change from baseline to 60 minutes post-intervention
measure: Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days
timeFrame: Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up
measure: Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale
timeFrame: Pain score assessed at 7 days post-intervention
measure: Opioid medications taken in the 7 days following the intervention
timeFrame: Measured at 7 days post-intervention
measure: Follow up visits related to low back pain in the 7 days following the intervention
timeFrame: Assessed at 7 days
measure: Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0
timeFrame: Assessed at 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Michael Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References: