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

NCT04168710 | Withdrawn Phase 1

• 2 other identifiers: 2000025328No NIH funding
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Total intravenous (IV) and oral narcotic analgesic use

  narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.

  From enrollment/baseline in the study through the study period, up to 24 hours.

Secondary Outcomes (10)

• Pain score

  Baseline (immediately following recruitment).

• Pain score

  30 minutes post-baseline

• Pain score

  1 hour post-baseline

• Pain score

  4 hours post-baseline

• Pain score

  12 hours post-baseline

Study Arms (2)

erector spinae plane block (ESP block) with bupivacaine

EXPERIMENTAL

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.

Drug: ESP block with bupivacaine

ESP block with saline/sham injection

PLACEBO COMPARATOR

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.

Other: Saline control/sham injection

Interventions

ESP block with bupivacaine 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.

erector spinae plane block (ESP block) with bupivacaine

Saline control/sham injection 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.

ESP block with saline/sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Rib Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Cristiana Baloescu, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The clinical team taking care of the patient as well as the patient will be blinded as to allocation to experimental or control group. The physician administering the block will also be blinded to the substance administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share