Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial

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This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

2020-02-10

2022-12-31

2022-12-31

Completed

Early phase I

62

Inclusion criteria: 1. Women presenting to Maternal Evaluation Unit at UAB hospital 2. Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal monitoring) 3. Complaint of headache 4. Minimal pain level of 4 on VRS Exclusion criteria: 1. Systolic BP \>= 140 or diastolic BP\>=90 with 1+ protein on urine dip 2. Systolic BP \>=160 or diastolic BP\>=105 3. Focal neurological symptoms 4. Altered level of consciousness defined as not being oriented to person, place, situation, and/or year 5. Complaint of seizure 6. Known under lying brain abnormality 7. Fever 8. Use of \>3 grams of acetaminophen in past 24hrs 9. ONB in the past 3 months 10. Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled Trail', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ACTUAL'}}

2023-12-20