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Local Anesthetic
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Phase 4
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-300 min
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial compares two headache treatments for pregnant women: a numbing injection at the back of the head and a combination of Tylenol and caffeine. Pregnant women are chosen because they need safe and effective headache treatments. The injection blocks pain signals, while the pill combination reduces pain and enhances relief.
Eligible Conditions
- Pregnancy
- Headache
- Occipital Nerve Block
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-300 min
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-300 min
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Response to Occipital Nerve Block in Pregnancy
Secondary study objectives
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Number of Participants With Need for Representation for Treatment of Headache With 28 Days
Response to Cross Over Treatment at 60 Min
+2 moreAwards & Highlights
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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Occipital Nerve blockExperimental Treatment1 Intervention
1. Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks.
2. Site of injection will be cleaned with an alcohol swab.
3. 5cc of 0.5% bupivacaine will be injected into both right and left occipital nerves using a 2.5 inch 25 gauge needle. The needle will be changed between injecting sites.
4. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
Group II: Oral Acetaminophen/Caffeine GroupActive Control1 Intervention
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Occipital Nerve Block
2020
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,313 Total Patients Enrolled