Erector Spinae Regional Anesthesia for Pain Control

Erector Spinae Regional Anesthesia for Pain Control in the Emergency Department

Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. They will rate their pain before and 30 minutes after the procedure using the ordinal categorical data on a numeric pain scale. Total patient opiate use will be gathered up to 8 hours after block completion.

Study Type

Interventional

Enrollment (Actual)

15

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

    • Pennsylvania
      • Ridley Park, Pennsylvania, United States, 19078
        • Crozer Chester Medical Center
      • Upland, Pennsylvania, United States, 19013
        • Crozer Chester Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Hospital
      • Temple, Texas, United States, 76508
        • Baylor Scott & White

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

No

Description

Inclusion Criteria:

  • Posterior/lateral rib or vertebral fractures
  • Pancreatitis or pancreatic cancer
  • Renal colic
  • Back pain

Exclusion Criteria:

  • Unstable vitals
  • Infection or open wound over insertion site
  • Prior allergic reaction to local anesthetic
  • Pregnant females
  • Patients <18 years old
  • Altered mentation

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector Spinae Plane Block (ESP) administration
Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.
Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously
Other Names:
  • Bupivacaine Hydrochloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scale Rating
Time Frame: Baseline to study procedure end (approximately 30 minutes)
Change in pain scale rating assessed by the participants on a scale from 0-10 with 0 indicating no pain and 10 indicating the most severe pain.
Baseline to study procedure end (approximately 30 minutes)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Morgan Ritz, MD, University of Texas Health Science Center San Antonio

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)

September 15, 2023

Primary Completion (Actual)

February 18, 2025

Study Completion (Actual)

February 18, 2025

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared in a peer reviewed publication after acceptance by the journal

IPD Sharing Time Frame

At study completion, after acceptance into a peer reviewed journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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