Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
NCT ID: NCT03951649
Last Updated: 2023-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2020-02-10
2022-12-31
Brief Summary
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Detailed Description
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See Figure 1 for the flow diagram depicting the patient's course through MEU. If eligible for inclusion, women will be randomly assigned to ONB or headache cocktail. Randomization will occur at time of enrollment. Prior to headache treatment 10-point visual/verbal rating scale (VRS) will be obtained. Treatment time is defined as time the patient takes the medication or the time that the needle is inserted into the greater occipital notch. At 60 min after treatment VRS will again be obtained by nursing staff or primary provider. If headache pain is resolved, defined as a VRS 0, the patient will be discharged to home (at the discretion of the managing team providing there are no other indications for further observation or admission). If pain continues to be present VRS will again be assessed at 120 min after treatment. If pain is not improved to mild range, defined as a VRS ≤ 3, or resolved, crossover treatment will be given. VRS will be obtained at 60 min after cross over treatment; if pain is resolved patient will be discharge to home. If pain continues to be present VRS will be obtained at 120 min after cross over treatment. If pain is not improved to mild pain or resolved; second line treatment of Promethazine 25mg/Benadryl 25mg will be given. VRS will again be obtained 60 min after second line treatment. If pain is not improved to mild pain (VRS ≤3) or resolved neurology consult will be considered. If at any point during treatment the patient develops new neurological symptoms study protocol will be stopped and neurology will be consulted.
Patients will be called 7 days after discharge to access short term outcomes (headache frequency since MEU visit, injection site complications, and satisfaction with treatment.) Patients will again be called at 28 days and a chart abstraction will be done to access for long term outcomes (recurrent presentation for headache to the MEU, maternal complications including preeclampsia, or fetal complications).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Occipital Nerve block
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.
Occipital Nerve Block
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.
Oral Acetaminophen/Caffeine Group
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
Occipital Nerve Block
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.
Interventions
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Occipital Nerve Block
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
16 Years
60 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Rachel Sinkey
Assistant Professor
Locations
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The Women and Infants center at the University of Alabama Birmingham
Birmingham, Alabama, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HA123456789
Identifier Type: -
Identifier Source: org_study_id