Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

Study Overview
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Brief Summary
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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.

Detailed Description
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This is an open label randomized controlled trial. Women who present to the MEU with headache will be assessed by trained nurse practitioners and/or OB/GYN residents. If the woman meets criteria for the study she will be enrolled by an MEU provider doing the primary assessment. 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).

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

Conditions
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Headache, Pregnancy Related, Occipital Nerve Block

Intervention / Treatment
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* Drug: Occipital Nerve Block


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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled Trail
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occipital Nerve block<br>Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved. | Drug: Occipital Nerve Block<br>* 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.<br>* Other names: Acetaminophen/Caffeine;|
| Active Comparator: Oral Acetaminophen/Caffeine Group<br>Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache) | Drug: Occipital Nerve Block<br>* 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.<br>* Other names: Acetaminophen/Caffeine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Response to Occipital Nerve Block in Pregnancy | Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail. | 60-300 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Treatment Within 2 Hours | Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain. Total Minimum score=0 Total Maximum score=10 Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved. | 2 hrs | 
| Number of Participants With Need for Crossover Treatment |  | 4 hours | 
| Response to Cross Over Treatment at 60 Min | Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain. Total Minimum score=0 Total Maximum score=10 Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved. | 60 min | 
| Number of Participants With Need for Second Line Treatment |  | 120 min | 
| Response to Second Line Treatment at 60 Min | Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain. Total Minimum score=0 Total Maximum score=10 Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved. | 180min | 
| Number of Participants With Need for Neurology Consult |  | 5 hours | 
| Number of Participants With Need for Admission for Treatment of Headache |  | 7 hours | 
| Number of Participants With Need for Representation for Treatment of Headache With 28 Days | Emergency department for treatment of headache since treatment asked at 28 day follow up | 28 days | 
| Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days |  | 28 days | 
| Number of Participants With Satisfaction of Response Treatment at 7 Days |  | 7 days | 
| Duration of Headache Free Period at 7 Days |  | 7 days | 
| Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days |  | 7 days | 
| Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis) | Other: Pain at injection site | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block