Your session is about to expire
← Back to Search
Local Anesthetic
Serratus Anterior Plane Block for Rib Fractures
Brooklyn, NY
Phase 4
Waitlist Available
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
Must not have
Unable to perform spirometry
Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of rib fracture pain, i.e. femur fracture, dislocated joint)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
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.
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.
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.
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 belowSelect...
I am 18 years old or older.
Select...
My pain level is 5 or higher.
Select...
I have two or more broken ribs on one side between my upper and middle back.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot perform a lung function test.
Select...
I have a painful injury that distracts from my rib fracture pain.
Select...
I have taken pain medication other than ketamine before the procedure.
Select...
My consciousness level is lower than normal.
Select...
I cannot give consent because of dementia or mental status changes.
Select...
I only have fractures in the ribs at my back.
Select...
I have no infections or cuts where I might receive an injection.
Select...
I need surgery as soon as possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Control
Other study objectives
Opiate Usage
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: 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.
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.
Find a Location
Closest Location:Maimonides Medical Center· Brooklyn, NY
Who is running the clinical trial?
Antonios LikourezosLead Sponsor
40 Previous Clinical Trials
8,631 Total Patients Enrolled
17 Trials studying Pain
1,218 Patients Enrolled for Pain
Judy Lin, MDPrincipal InvestigatorMaimonides Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drug or alcohol abuse.I am 18 years old or older.My pain level is 5 or higher.I cannot perform a lung function test.I have two or more broken ribs on one side between my upper and middle back.You have an allergy to certain types of anesthesia called amide-type local anesthetics.I have a painful injury that distracts from my rib fracture pain.I have taken pain medication other than ketamine before the procedure.My consciousness level is lower than normal.I cannot give consent because of dementia or mental status changes.I only have fractures in the ribs at my back.I have no infections or cuts where I might receive an injection.You are allergic to acetaminophen.You are allergic to morphine sulfate.I have a long-term pain condition and regularly use painkillers.I need surgery as soon as possible.You are currently pregnant.You have a wound that goes through your skin or other tissues.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo injection group
- Group 2: serratus anterior plane block group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.