Phase 4
Completed N=62
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Headache · Pregnancy Related · Occipital Nerve Block
Source: ClinicalTrials.gov NCT03951649 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants With Response to Occipital Nerve Block in Pregnancy — 20; 16 Participants — p=0.30
◆ Published Evidence
Emerging
4citations · ~1 / year
Occipital Nerve Block Compared With Acetaminophen and Caffeine for Headache Treatment in Pregnancy: A Randomized Controlled 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.
Linked Publications
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Occipital Nerve Block Compared With Acetaminophen and Caffeine for Headache Treatment in Pregnancy: A Randomized Controlled Trial.
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 |
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)
Data sourced from ClinicalTrials.gov (NCT03951649) and the linked publication. 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. Informational only — not medical advice.