Clinical trial NCT04168710: Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
Official title: Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rib Fractures
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 72
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 study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.

Detailed description: Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.

Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.

Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.

Eligibility criteria: Inclusion Criteria:

1. radiographic evidence of unilateral rib fracture(s).
2. able to consent and actively participate in the study.
3. moderate to severe pain (defined as numerical pain rating score \>/ 4 ) at time of enrollment.

Exclusion Criteria:

1. known allergy or hypersensitivity to local anesthetics or morphine.
2. infection at site of ESP block placement.
3. depth over 5 cm from skin to transverse process visualized with ultrasound.
4. additional injuries that preclude positioning for ESP block placement.
5. severe traumatic brain or spinal cord injury.
6. severe altered mental status, such that pain could not be assessed.
7. extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
8. adjunctive epidural catheter pain control.
9. other regional anesthetic blocks.
10. pregnancy or prisoner status.
11. unstable vital signs.

Primary outcomes:
measure: Total intravenous (IV) and oral narcotic analgesic use
timeFrame: From enrollment/baseline in the study through the study period, up to 24 hours.
Secondary outcomes:
measure: Pain score
timeFrame: Baseline (immediately following recruitment).
measure: Pain score
timeFrame: 30 minutes post-baseline
measure: Pain score
timeFrame: 1 hour post-baseline
measure: Pain score
timeFrame: 4 hours post-baseline
measure: Pain score
timeFrame: 12 hours post-baseline
measure: Pain score
timeFrame: 24 hours post-baseline
measure: Hospital length of stay (LOS)
timeFrame: From hospital admission to hospital discharge, up to 30 days.
measure: Number of Patients Who Develop Pneumonia
timeFrame: From admission to 30 days from admission.
measure: Adverse events associated with the nerve block itself.
timeFrame: Within two hours of administration of the nerve block.
measure: Total non-narcotic analgesic use.
timeFrame: From enrollment/baseline in the study through the study period, up to 24 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Cristiana Baloescu, MD
role: PRINCIPAL_INVESTIGATOR
References: