Ultrasound-guided Erector Spinae Plane Blocks

June 27, 2023 updated by: Daniel Stephens, Mayo Clinic

Erector Spinae Plane Block for Rib Fractures: A Pilot Study

The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients 18 years old or older.
  • Patients with one or more acute traumatic rib fractures.

Exclusion Criteria:

  • Inability to position appropriately.
  • Unconscious or heavily sedated.
  • Patients who are critically ill such that care should not be delayed for regional anesthesia.
  • Patients under the age of 18 years old.
  • Vulnerable populations including prison inmates and pregnant patients.
  • Overlying skin infection, wound, or dressing/equipment (i.e., Chest tube).
  • Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
  • Known or documented allergy to ropivacaine or other amide local anesthetic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EPSB for rib fractures
Procedure: EPSB for rib fractures
EPSB for rib fractures
Drug: Ropivacaine
Standard of care weight-based optimal Ropivacaine dosing for ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success rate
Time Frame: 12 months
Measuring the Number of successful ESPB procedures performed in the ED and ICU
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Daniel Stephens, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-007896

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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