Clinical trial NCT03951649: Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Official title: Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Pregnancy Related
Occipital Nerve Block
Keywords: headache
Pregnancy
Acute treatment
Emergency department
Occipital nerve block
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 62
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled Trail
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Response to Occipital Nerve Block in Pregnancy
timeFrame: 60-300 min
Secondary outcomes:
measure: Response to Treatment Within 2 Hours
timeFrame: 2 hrs
measure: Number of Participants With Need for Crossover Treatment
timeFrame: 4 hours
measure: Response to Cross Over Treatment at 60 Min
timeFrame: 60 min
measure: Number of Participants With Need for Second Line Treatment
timeFrame: 120 min
measure: Response to Second Line Treatment at 60 Min
timeFrame: 180min
measure: Number of Participants With Need for Neurology Consult
timeFrame: 5 hours
measure: Number of Participants With Need for Admission for Treatment of Headache
timeFrame: 7 hours
measure: Number of Participants With Need for Representation for Treatment of Headache With 28 Days
timeFrame: 28 days
measure: Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
timeFrame: 28 days
measure: Number of Participants With Satisfaction of Response Treatment at 7 Days
timeFrame: 7 days
measure: Duration of Headache Free Period at 7 Days
timeFrame: 7 days
measure: Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
timeFrame: 7 days
measure: Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
timeFrame: 7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Women and Infants center at the University of Alabama Birmingham
state: Alabama
Study officials:
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