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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951649
• Other study ID #: HA123456789
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Occipital Nerve Block
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	The Women and Infants center at the University of Alabama Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (24)

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Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12. — View Citation

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Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14. — View Citation

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Voigt CL, Murphy MO. Occipital nerve blocks in the treatment of headaches: safety and efficacy. J Emerg Med. 2015 Jan;48(1):115-29. doi: 10.1016/j.jemermed.2014.09.007. Epub 2014 Oct 18. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 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.	60-300 min
Secondary	Response to Treatment Within 2 Hours	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
Secondary	Number of Participants With Need for Crossover Treatment		4 hours
Secondary	Response to Cross Over Treatment at 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
Secondary	Number of Participants With Need for Second Line Treatment		120 min
Secondary	Response to Second Line Treatment at 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.	180min
Secondary	Number of Participants With Need for Neurology Consult		5 hours
Secondary	Number of Participants With Need for Admission for Treatment of Headache		7 hours
Secondary	Number of Participants With Need for Representation for Treatment of Headache With 28 Days	Emergency department for treatment of headache since treatment asked at 28 day follow up	28 days
Secondary	Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days		28 days
Secondary	Number of Participants With Satisfaction of Response Treatment at 7 Days		7 days
Secondary	Duration of Headache Free Period at 7 Days		7 days
Secondary	Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days		7 days
Secondary	Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)	Other: Pain at injection site	7 days