Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia

Yale University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Rib Fractures

Treatments: Drug: ESP block with bupivacaine; Other: Saline control/sham injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04168710

2000025328

No NIH funding (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

erector spinae plane block (ESP block) with bupivacaine

Experimental group

Description:

Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.

Treatment:

Drug: ESP block with bupivacaine

ESP block with saline/sham injection

Placebo Comparator group

Description:

Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.

Treatment:

Other: Saline control/sham injection