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

NCT ID: NCT04168710

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-05-31

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.

Conditions

Rib Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

erector spinae plane block (ESP block) with bupivacaine

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.

Group Type: EXPERIMENTAL

ESP block with bupivacaine

Intervention Type: DRUG

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.

ESP block with saline/sham injection

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.

Group Type: PLACEBO_COMPARATOR

Saline control/sham injection

Intervention Type: OTHER

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.

Interventions

ESP block with bupivacaine

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.

Intervention Type: DRUG

Saline control/sham injection

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristiana Baloescu, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000025328

Identifier Type: -

Identifier Source: org_study_id