Ultrasound-guided Erector Spinae Plane Blocks

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04916691
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47.5
• Patients Per Site Per Month: 0.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Rib Fractures	Procedure: EPSB for rib fractures; Drug: Ropivacaine	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Erector Spinae Plane Block for Rib Fractures: A Pilot Study
• Actual Study Start Date: May 15, 2021
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: EPSB for rib fractures 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

Outcome Measures

Primary Outcome Measures

1. Procedural success rate [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Daniel Stephens, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Daniel Stephens, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04916691
• Other Study ID Numbers: 19-007896
• First Posted: Jun 7, 2021
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Rib Fractures; Ropivacaine

Study Results

No Results Posted as of Jun 24, 2022