Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Condition: Headache; Pregnancy Related; Occipital Nerve Block
MeSH terms: Headache
Study type: Interventional
Phase: Phase 4

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).
    

Intervention name(s): Occipital Nerve Block
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Acetaminophen/Caffeine
Intervention MeSH terms: Acetaminophen; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled Trail
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: headache; Pregnancy; Acute treatment; Emergency department; Occipital nerve block