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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
The Women and Infants center at the University of Alabama Birmingham
Birmingham, Alabama, United States
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.
Time frame: 60-300 min
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.
Time frame: 2 hrs
Number of Participants With Need for Crossover Treatment
Time frame: 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.
Time frame: 60 min
Number of Participants With Need for Second Line Treatment
Time frame: 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.
Time frame: 180min
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Number of Participants With Need for Neurology Consult
Time frame: 5 hours
Number of Participants With Need for Admission for Treatment of Headache
Time frame: 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
Time frame: 28 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
Time frame: 28 days
Number of Participants With Satisfaction of Response Treatment at 7 Days
Time frame: 7 days
Duration of Headache Free Period at 7 Days
Time frame: 7 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
Time frame: 7 days
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Other: Pain at injection site
Time frame: 7 days