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Analgesic
CINB + Medical Therapy for Rib Fractures
Phase 4
Recruiting
Led By Zachary Warriner, MD
Research Sponsored by Zachary Warriner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will compare CINB + medical therapy to medical therapy alone to see if CINB helps treat rib fractures. It will look at the effectiveness of CINB and compare it to non-steroidal and opioid medications.
Who is the study for?
This trial is for adults over 18 with multiple rib fractures who agree to try a pain treatment involving nerve blocks. They must be willing to give informed consent. People can't join if they refuse the nerve block therapy, are allergic to the medication used in the study, already use an epidural catheter, or are prisoners.Check my eligibility
What is being tested?
The study is testing whether adding continuous intercostal nerve block (CINB) to standard medical care (pain relief with non-steroidal anti-inflammatory drugs and opioids) provides better pain management for patients with rib fractures than standard care alone.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site from CINB, typical opioid-related issues like drowsiness or constipation, and potential risks associated with non-steroidals such as stomach upset.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of hospital stay
Secondary outcome measures
Modified Morphine Equivalent (MME) differences
Patient daily pain scores
Patient reported quality of life
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: continuous intercostal nerve block (CINB)Experimental Treatment2 Interventions
patients admitted to the adult trauma service with rib fractures who are receiving CINB
Group II: standard medical careActive Control1 Intervention
patients admitted to the adult trauma service with rib fractures who are receiving standard medical care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
Zachary WarrinerLead Sponsor
Zachary Warriner, MDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using an epidural catheter.I am 18 years old or older.I have chosen not to undergo CINB therapy.I am identified as a candidate for nerve block therapy for my rib fracture pain.
Research Study Groups:
This trial has the following groups:- Group 1: continuous intercostal nerve block (CINB)
- Group 2: standard medical care
Awards:
This trial has 3 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned continuous intercostal nerve block (CINB) for medical use?
"CINB has already been approved, so its safety is rated a 3 on our scale. This denotes the Phase 4 designation of this treatment's clinical trial."
Answered by AI
Are there any available openings to participate in this clinical research?
"Unfortunately, this medical trial is no longer accepting patients; however, there are 353 other clinical studies canvassing for participants. According to information posted on ClinicalTrials.gov, the initial post was made December 1st and last updated November 29th of 2022."
Answered by AI
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