Continuous Erector Spinae Plane Blocks for Rib Fractures

Recruiting in Palo Alto (17 mi)

Overseen byBrian M Ilfeld, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, San Diego

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death. One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures. The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.

Research Team

John J Finneran IV, MD

Principal Investigator

University of California, San Diego

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

regional anesthetic requested by the admitting service

having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)

You are willing to have a catheter inserted near your nerves and receive fluid treatment as part of the study.

Exclusion Criteria

You have a condition called flail chest.

inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access).

You have an injury, other than a rib fracture, that affects your ability to breathe deeply.

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Treatment Details

Interventions

Erector Spinae Plane Block (Procedure)
Placebo (Local Anesthetic)
Ropivacaine 0.3% (Local Anesthetic)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 Intervention

This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)

Group II: PlaceboPlacebo Group1 Intervention

This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline