Back to resultsUltrasound-guided Erector Spinae Plane Blocks
Primary Purpose
Rib Fractures
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
EPSB for rib fractures
Ropivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Rib Fractures
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
EPSB for rib fractures
Arm Description
EPSB for rib fractures
Outcomes
Primary Outcome Measures
Procedural success rate
Measuring the Number of successful ESPB procedures performed in the ED and ICU
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04916691
Brief Title
Ultrasound-guided Erector Spinae Plane Blocks
Official Title
Erector Spinae Plane Block for Rib Fractures: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPSB for rib fractures
Arm Type
Other
Arm Description
EPSB for rib fractures
Intervention Type
Procedure
Intervention Name(s)
EPSB for rib fractures
Intervention Description
EPSB for rib fractures
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Standard of care weight-based optimal Ropivacaine dosing for ESPB
Primary Outcome Measure Information:
Title
Procedural success rate
Description
Measuring the Number of successful ESPB procedures performed in the ED and ICU
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Stephens, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Ultrasound-guided Erector Spinae Plane Blocks
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