Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 16 Years and 60 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled Trail
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Occipital Nerve block
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
    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 names:
    • Acetaminophen/Caffeine
Active Comparator
Oral Acetaminophen/Caffeine Group
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
  • Drug: 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 names:
    • Acetaminophen/Caffeine

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.