NCT04916691

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 20, 2021

Last Update Submit

June 27, 2023

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

  • Procedural success rate

    Measuring the Number of successful ESPB procedures performed in the ED and ICU

    12 months

Study Arms (1)

EPSB for rib fractures

OTHER

EPSB for rib fractures

Procedure: EPSB for rib fracturesDrug: Ropivacaine

Interventions

EPSB for rib fracturesPROCEDURE

EPSB for rib fractures

EPSB for rib fractures
RopivacaineDRUG

Standard of care weight-based optimal Ropivacaine dosing for ESPB

EPSB for rib fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Rib Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Daniel Stephens, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 7, 2021

Study Start

May 15, 2021

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

US(1)