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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Pregnancy Related; Headache; Occipital Nerve Block

Treatments: Drug: Occipital Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03951649

HA123456789

Details and patient eligibility

About

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.

Full 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).

Enrollment: 62 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Occipital Nerve block

Experimental group

Description:

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.

Treatment:

Drug: Occipital Nerve Block

Oral Acetaminophen/Caffeine Group

Active Comparator group

Description:

Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Treatment:

Drug: Occipital Nerve Block