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Local Anesthetic
Experimental (SAPB) for Traumatic Rib Fracture(s)
Phase 4
Waitlist Available
Led By Josh Luftig, PA
Research Sponsored by Andrew A Herring
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 20, 40, 60 minutes
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.
Eligible Conditions
- Multiple Rib Fractures
- Traumatic Rib Fracture(s)
- Rib Fractures
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20, 40, 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20, 40, 60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Secondary study objectives
Adverse events
Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups
Difference in total morphine equivalents
+3 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (SAPB)Experimental Treatment1 Intervention
Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.
Group II: ControlActive Control1 Intervention
Patients randomized to the control arm receive usual pain control treatment in the emergency department.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
Andrew A HerringLead Sponsor
Oregon Health and Science UniversityOTHER
1,002 Previous Clinical Trials
7,412,260 Total Patients Enrolled
University of California, Los AngelesOTHER
1,560 Previous Clinical Trials
10,258,864 Total Patients Enrolled
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