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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

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Who is running the clinical trial?

Antonios LikourezosLead Sponsor

38 Previous Clinical Trials

8,488 Total Patients Enrolled

17 Trials studying Pain

1,335 Patients Enrolled for Pain

Judy Lin, MDPrincipal InvestigatorMaimonides Medical Center

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04530149 — Phase 4

Pain Research Study Groups: serratus anterior plane block group, Placeoo injection group

Pain Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT04530149 — Phase 4

Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530149 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what kind of medical condition is the serratus anterior plane block group usually applied?

"The serratus anterior plane block group has been successfully utilized to treat catarrh, rhinorrhoea, musculoskeletal pain and muscle spasms."

Answered by AI

What risks do patients incur when receiving a serratus anterior plane block?

"Our team's assessment of serratus anterior plane block group yielded an overall score of 3, signifying that this treatment is already approved and accepted."

Answered by AI

Does this experiment permit elderly volunteers to participate?

"The prerequisites for this medical experiment requires that all participants are between 18 and 120 years old. Separately, there is a set of 104 clinical trials designed exclusively for minors and another collection of 324 studies tailored to the elderly."

Answered by AI

Would I be eligible to become part of this research endeavor?

"For this trial, the necessary parameters include being between 18 and 120 years old with a pain score of 5 or higher. Of these eligible patients, 90 will be chosen to participate in the study."

Answered by AI

How many study participants are enrolled in this research endeavor?

"Affirmative. The clinical trial's data hosted on the website confirms that this research is presently recruiting participants, having first been posted on November 1st 2021 and last amended on November 22nd 2021. 90 individuals are being sought from a single medical facility for inclusion in the study."

Answered by AI

Are there any vacancies available to participants in this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov denotes that this study is actively searching for participants, which was initially posted on November 1st 2021 and recently updated on the 22nd of the same month. 90 candidates need to be sourced from a single trial site."

Answered by AI

Are there any additional experiments that have been conducted on the effects of serratus anterior plane block?

"Currently, there are 89 studies being conducted on serratus anterior plane block group with 26 of them in Phase 3. While the majority originate from Pittsburgh, Pennsylvania, these trials span an incredible 1003 locations around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures

Antonios Likourezos 2021. "Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04530149.

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