What is the mechanism of action of this treatment?

Local anesthetic blocks, such as the Serratus Anterior Plane Block (SAPB), work by inhibiting nerve signal transmission in the targeted area, reducing pain sensation. This is achieved by injecting anesthetic agents near specific nerves, blocking sodium channels, and preventing the propagation of pain signals to the brain. This mechanism is crucial for pain patients as it provides targeted pain relief, minimizes the need for systemic opioids, and can improve respiratory function by allowing better chest expansion and cough effort, which is particularly important in patients with rib fractures.

What side effects are associated with this type of intervention?

Local anesthetic blocks, such as the Serratus Anterior Plane Block (SAPB), are generally well-tolerated but can have side effects including infection at the injection site, bleeding, and nerve damage. Other non-opioid pain management strategies, such as NSAIDs, can cause gastrointestinal issues, cardiovascular risks, and renal impairment. Intravenous lidocaine may lead to systemic toxicity, manifesting as dizziness, tinnitus, or even seizures. Ketamine, another non-opioid option, can cause psychological effects like hallucinations and confusion. These treatments aim to reduce pain while minimizing the use of opioids, which carry risks of addiction and respiratory depression.

What prior FDA approvals exist?

The FDA has approved several local anesthetics for pain management, including bupivacaine, lidocaine, and ropivacaine, which are commonly used in nerve blocks similar to the Serratus Anterior Plane Block (SAPB). These local anesthetics work by blocking nerve signals in the targeted area, providing pain relief. Additionally, the FDA has approved various formulations and delivery methods for these anesthetics, such as injections and topical applications, to manage acute and chronic pain effectively. These treatments are often used in perioperative settings and for conditions like rib fractures to improve pain control and respiratory function.

What other types of research exist?

Promising alternatives to SAPB for pain management in 2024 include: 1) Erector Spinae Plane Block (ESPB), which provides effective analgesia for thoracic and abdominal surgeries with a favorable safety profile. 2) Pectoral Nerve Blocks (Pecs I and II), which are useful for chest wall surgeries and can reduce opioid consumption. 3) Continuous Peripheral Nerve Blocks (CPNB), which offer prolonged pain relief through continuous infusion of local anesthetics. 4) Cryoneurolysis, a technique that uses extreme cold to temporarily block nerve function, providing long-lasting pain relief without the need for continuous medication.

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Local Anesthetic

Serratus Anterior Plane Block for Rib Fractures

Phase 4

Recruiting

Led By Judy Lin, MD

Research Sponsored by Antonios Likourezos

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Pain Score 5 or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial is testing whether the serratus anterior plane block (SAPB) is better than conventional management with medications for patients with multiple rib fractures. The primary objective is to evaluate whether SAPB results in a greater improvement in percent predicted vital capacity compared to standard therapy with a sham injection.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site like swelling or infection. There could also be allergic reactions to the local anesthetics used in SAPB. Side effects from acetaminophen can range from nausea to liver damage in severe cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My pain level is 5 or higher.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vital Capacity

Secondary outcome measures

Pain Control

Other outcome measures

Opiate Usage

Trial Design

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: Placeoo 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthetic blocks, such as the Serratus Anterior Plane Block (SAPB), work by inhibiting nerve signal transmission in the targeted area, reducing pain sensation. This is achieved by injecting anesthetic agents near specific nerves, blocking sodium channels, and preventing the propagation of pain signals to the brain. This mechanism is crucial for pain patients as it provides targeted pain relief, minimizes the need for systemic opioids, and can improve respiratory function by allowing better chest expansion and cough effort, which is particularly important in patients with rib fractures.