Phase 4 N=62 Randomized Treatment

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

Headache · Pregnancy Related · Occipital Nerve Block

Bottom Line

View on ClinicalTrials.gov: NCT03951649 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Number of Participants With Response to Occipital Nerve Block in Pregnancy — 20; 16 Participants — p=0.30

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Occipital Nerve Block (Drug)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Response to Occipital Nerve Block in Pregnancy	20; 16	0.30
SECONDARY Response to Treatment Within 2 Hours	6.0; 6.5	>0.99
SECONDARY Number of Participants With Need for Crossover Treatment	9; 14	0.19
SECONDARY Response to Cross Over Treatment at 60 Min	6; 3	0.028 sig
SECONDARY Number of Participants With Need for Second Line Treatment	5; 5	1.00
SECONDARY Response to Second Line Treatment at 60 Min	6; 4	0.61
SECONDARY Number of Participants With Need for Neurology Consult	4; 2	0.43
SECONDARY Number of Participants With Need for Admission for Treatment of Headache	0; 0	—
SECONDARY Number of Participants With Need for Representation for Treatment of Headache With 28 Days	5; 1	0.19
SECONDARY Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days	9; 4	0.18
SECONDARY Number of Participants With Satisfaction of Response Treatment at 7 Days	12; 10; 5; 4; 3; 5	0.92
SECONDARY Duration of Headache Free Period at 7 Days	6; 1	0.13
SECONDARY Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days	7; 2	0.14
SECONDARY Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)	0; 2	0.23

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03951649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.