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Completed

NCT Number: NCT03951649

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

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.

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Key information

Age range

16 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Women and Infants center at the University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women presenting to Maternal Evaluation Unit at UAB hospital
  • Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal monitoring)
  • Complaint of headache
  • Minimal pain level of 4 on VRS

Exclusion criteria

  • Systolic BP >= 140 or diastolic BP>=90 with 1+ protein on urine dip
  • Systolic BP >=160 or diastolic BP>=105
  • Focal neurological symptoms
  • Altered level of consciousness defined as not being oriented to person, place, situation, and/or year
  • Complaint of seizure
  • Known under lying brain abnormality
  • Fever
  • Use of >3 grams of acetaminophen in past 24hrs
  • ONB in the past 3 months
  • Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)

Treatment and study plan

Occipital Nerve Block

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. Number of Participants With Need for Crossover Treatment

    Time frame: 4 hours

  3. 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.

  4. Number of Participants With Need for Second Line Treatment

    Time frame: 120 min

  5. 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.

  6. Number of Participants With Need for Neurology Consult

    Time frame: 5 hours

  7. Number of Participants With Need for Admission for Treatment of Headache

    Time frame: 7 hours

  8. 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

  9. Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days

    Time frame: 28 days

  10. Number of Participants With Satisfaction of Response Treatment at 7 Days

    Time frame: 7 days

  11. Duration of Headache Free Period at 7 Days

    Time frame: 7 days

  12. Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days

    Time frame: 7 days

  13. Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)

    Time frame: 7 days

    Other: Pain at injection site

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 15, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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