Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951649
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Elisa T Bushman, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Headache Pregnancy Related Occipital Nerve Block Drug: Occipital Nerve Block Phase 4

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled Trail
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Headache

Arm Intervention/treatment
Experimental: Occipital Nerve block
  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.
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 Name: 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 Name: Acetaminophen/Caffeine




Primary Outcome Measures :
  1. Response to occipital nerve block in pregnancy [ Time Frame: 60-300 min ]
    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.


Secondary Outcome Measures :
  1. Response to treatment within 2 hours [ Time Frame: 2 hrs ]
  2. Need for crossover treatment [ Time Frame: 4 hours ]
  3. Response to cross over treatment at 60 or 120 min [ Time Frame: 60-120 min ]
  4. Need for second line treatment [ Time Frame: 120 min ]
  5. Response to second line treatment at 60 min [ Time Frame: 180min ]
  6. Need for neurology consult [ Time Frame: 5 hours ]
  7. Need for admission for treatment of headache [ Time Frame: 7 hours ]
  8. Need for representation for treatment of headache with 28 days [ Time Frame: 28 days ]
  9. Development of hypertensive disease of pregnancy within 28 days [ Time Frame: 28 days ]
  10. Satisfaction with treatment at 7 days [ Time Frame: 7 days ]
  11. Duration of headache free period at 7 days [ Time Frame: 7 days ]
  12. Development of hypertensive disease of pregnancy within 7 days [ Time Frame: 7 days ]
  13. Injection site complication (infection, hematoma, and ecchymosis) [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Females
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951649


Contacts
Layout table for location contacts
Contact: Elisa T Bushman, MD 205-934-9188 ebushman@uabmc.edu
Contact: Rachel G Sinkey, MD (205) 934-5612 rsinkey@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham

Publications of Results:

Layout table for additonal information
Responsible Party: Elisa T Bushman, Fellow/Instructor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03951649     History of Changes
Other Study ID Numbers: HA123456789
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Elisa T Bushman, University of Alabama at Birmingham:
headache
Pregnancy
Acute treatment
Emergency department
Occipital nerve block
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents