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

Phase 4

Completed

• Conditions: Pregnancy Related; Headache; Occipital Nerve Block
• Interventions: Drug: Occipital Nerve Block

• Registration Number: NCT03951649
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2020-02-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2023-10-17
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Results First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Acetaminophen/Caffeine Group	Occipital Nerve Block	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
Occipital Nerve block	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Response to Occipital Nerve Block in Pregnancy	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

Name	Time	Method
Response to Treatment Within 2 Hours	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.
Response to Second Line Treatment at 60 Min	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.
Number of Participants With Need for Admission for Treatment of Headache	7 hours
Response to Cross Over Treatment at 60 Min	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.
Number of Participants With Satisfaction of Response Treatment at 7 Days	7 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days	7 days
Number of Participants With Need for Crossover Treatment	4 hours
Number of Participants With Need for Second Line Treatment	120 min
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days	28 days
Number of Participants With Need for Neurology Consult	5 hours
Number of Participants With Need for Representation for Treatment of Headache With 28 Days	28 days	Emergency department for treatment of headache since treatment asked at 28 day follow up
Duration of Headache Free Period at 7 Days	7 days
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)	7 days	Other: Pain at injection site

Trial Locations

Locations (1)

The Women and Infants center at the University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States