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

Primary Purpose

Headache, Pregnancy Related, Occipital Nerve Block

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Occipital Nerve Block
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • The Women and Infants center at the University of Alabama Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Occipital Nerve block

Oral Acetaminophen/Caffeine Group

Arm Description

Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.

Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response to treatment within 2 hours
Need for crossover treatment
Response to cross over treatment at 60 or 120 min
Need for second line treatment
Response to second line treatment at 60 min
Need for neurology consult
Need for admission for treatment of headache
Need for representation for treatment of headache with 28 days
Development of hypertensive disease of pregnancy within 28 days
Satisfaction with response treatment at 7 days
Duration of headache free period at 7 days
Development of hypertensive disease of pregnancy within 7 days
Injection site complication (infection, hematoma, and ecchymosis)

Full Information

First Posted
May 14, 2019
Last Updated
January 4, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03951649
Brief Title
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Official Title
Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Pregnancy Related, Occipital Nerve Block
Keywords
headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled Trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occipital Nerve block
Arm Type
Experimental
Arm Description
Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
Arm Title
Oral Acetaminophen/Caffeine Group
Arm Type
Active Comparator
Arm Description
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
Intervention Type
Drug
Intervention Name(s)
Occipital Nerve Block
Other Intervention Name(s)
Acetaminophen/Caffeine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response to occipital nerve block in pregnancy
Description
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
Secondary Outcome Measure Information:
Title
Response to treatment within 2 hours
Time Frame
2 hrs
Title
Need for crossover treatment
Time Frame
4 hours
Title
Response to cross over treatment at 60 or 120 min
Time Frame
60-120 min
Title
Need for second line treatment
Time Frame
120 min
Title
Response to second line treatment at 60 min
Time Frame
180min
Title
Need for neurology consult
Time Frame
5 hours
Title
Need for admission for treatment of headache
Time Frame
7 hours
Title
Need for representation for treatment of headache with 28 days
Time Frame
28 days
Title
Development of hypertensive disease of pregnancy within 28 days
Time Frame
28 days
Title
Satisfaction with response treatment at 7 days
Time Frame
7 days
Title
Duration of headache free period at 7 days
Time Frame
7 days
Title
Development of hypertensive disease of pregnancy within 7 days
Time Frame
7 days
Title
Injection site complication (infection, hematoma, and ecchymosis)
Time Frame
7 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant Females
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
The Women and Infants center at the University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

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