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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
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of hospital stay
Secondary study objectives
Modified Morphine Equivalent (MME) differences
Patient daily pain scores
Patient reported quality of life
+3 more

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Non steroidal anti-inflammatory drug and opioids (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05642026 — Phase 4
Rib Fractures Research Study Groups: continuous intercostal nerve block (CINB), standard medical care
Rib Fractures Clinical Trial 2023: Non steroidal anti-inflammatory drug and opioids Highlights & Side Effects. Trial Name: NCT05642026 — Phase 4
Non steroidal anti-inflammatory drug and opioids (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05642026 — Phase 4
~NaN spots leftby Dec 2024
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