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

November 30, 2023 updated by: Rachel Sinkey, University of Alabama at Birmingham

Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The Women and Infants center at the University of Alabama Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 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.
60-300 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to Treatment Within 2 Hours
Time Frame: 2 hrs

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.
2 hrs
Number of Participants With Need for Crossover Treatment
Time Frame: 4 hours
4 hours
Response to Cross Over Treatment at 60 Min
Time Frame: 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.
60 min
Number of Participants With Need for Second Line Treatment
Time Frame: 120 min
120 min
Response to Second Line Treatment at 60 Min
Time Frame: 180min

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.
180min
Number of Participants With Need for Neurology Consult
Time Frame: 5 hours
5 hours
Number of Participants With Need for Admission for Treatment of Headache
Time Frame: 7 hours
7 hours
Number of Participants With Need for Representation for Treatment of Headache With 28 Days
Time Frame: 28 days
Emergency department for treatment of headache since treatment asked at 28 day follow up
28 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
Time Frame: 28 days
28 days
Number of Participants With Satisfaction of Response Treatment at 7 Days
Time Frame: 7 days
7 days
Duration of Headache Free Period at 7 Days
Time Frame: 7 days
7 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
Time Frame: 7 days
7 days
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Time Frame: 7 days
Other: Pain at injection site
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA123456789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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