Serratus Anterior Plane Block for Rib Fractures

Recruiting in Palo Alto (17 mi)

Overseen byJudy Lin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Antonios Likourezos

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new pain relief method called SAPB for patients with multiple broken ribs. SAPB involves injecting a numbing medicine near the ribs to reduce pain. This helps patients breathe deeply and cough properly, which can prevent lung complications. Recently, with the development of ultrasonic technology and equipment, SAPB has entered the era of visualization, further improving the safety and success.

Eligibility Criteria

This trial is for adults over 18 with at least two acute rib fractures on one side, causing significant pain (score of 5 or more). It's not for those with infections at the injection site, only backside rib fractures, certain drug allergies, pregnancy, need for urgent surgery, substance abuse history, low blood pressure, mental status issues preventing consent or spirometry performance.

Inclusion Criteria

I am 18 years old or older.

My pain level is 5 or higher.

I have two or more broken ribs on one side between my upper and middle back.

Exclusion Criteria

You have a history of drug or alcohol abuse.

I cannot perform a lung function test.

You have an allergy to certain types of anesthesia called amide-type local anesthetics.

See 13 more

Treatment Details

Interventions

Acetaminophen ()
Bupivacaine (Local Anesthetic)
Saline ()

Trial OverviewThe study tests if a Serratus Anterior Plane Block (SAPB), guided by ultrasound to manage pain and improve lung function in patients with multiple rib fractures is better than standard treatment. The main goal is to see if SAPB increases vital capacity more effectively than a sham procedure.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: serratus anterior plane block groupActive Control2 Interventions

The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.

Group II: Placebo injection groupPlacebo Group2 Interventions

The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Marcaine for: