Headache, Occipital Nerve Block, Pregnancy Related
Conditions
Keywords
headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block
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).
Interventions
DRUGOccipital 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled Trail
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Headache Free Period at 7 Days | 7 days | — |
| Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days | 7 days | — |
| Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis) | 7 days | Other: Pain at injection site |
| 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. |
| Number of Participants With Need for Crossover Treatment | 4 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 | — |
| 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 Neurology Consult | 5 hours | — |
| Number of Participants With Need for Admission for Treatment of Headache | 7 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 |
| Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days | 28 days | — |
| Number of Participants With Need for Second Line Treatment | 120 min | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Oral Acetaminophen/Caffeine Group Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache) | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Occipital Nerve Block | Oral Acetaminophen/Caffeine Group | Total |
|---|---|---|---|
| Age, Continuous | 28.4 years STANDARD_DEVIATION 4.8 | 27.3 years STANDARD_DEVIATION 5.3 | 27.9 years STANDARD_DEVIATION 5.1 |
| BMI at Randomization | 36.4 kg/m^2 STANDARD_DEVIATION 10.5 | 37.2 kg/m^2 STANDARD_DEVIATION 10.7 | 36.8 kg/m^2 STANDARD_DEVIATION 10.5 |
| Chronic Hypertension | 9 Participants | 4 Participants | 13 Participants |
| Diabetes | 6 Participants | 3 Participants | 9 Participants |
| Gestational Age at randomization (weeks) | 28.2 weeks STANDARD_DEVIATION 8.3 | 27.2 weeks STANDARD_DEVIATION 7.5 | 27.7 weeks STANDARD_DEVIATION 7.9 |
| Headache prior to pregnancy | 12 Participants | 18 Participants | 30 Participants |
| Insurance Status None/Self-pay | 2 Participants | 1 Participants | 3 Participants |
| Insurance Status Private | 12 Participants | 4 Participants | 16 Participants |
| Insurance Status Public | 17 Participants | 26 Participants | 43 Participants |
| Known primary headache disorder Migraine | 8 Participants | 12 Participants | 20 Participants |
| Known primary headache disorder Overall | 9 Participants | 14 Participants | 23 Participants |
| Known primary headache disorder Tension | 1 Participants | 2 Participants | 3 Participants |
| Marijuana Use | 2 Participants | 2 Participants | 4 Participants |
| Nulliparous | 6 Participants | 8 Participants | 14 Participants |
| Other Illicit Substance Use | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black, Non-Hispanic | 15 Participants | 22 Participants | 37 Participants |
| Race/Ethnicity, Customized Race Hispanic | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White, Non-Hispanic | 14 Participants | 6 Participants | 20 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 31 Participants | 31 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco Use | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 3 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
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.
Time frame: 60-300 min
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Response to Occipital Nerve Block in Pregnancy | 20 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Response to Occipital Nerve Block in Pregnancy | 16 Participants |
p-value: 0.3Chi-squared
Secondary
Duration of Headache Free Period at 7 Days
Time frame: 7 days
Population: Patients who responded to specific question at 7 day follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Occipital Nerve Block | Duration of Headache Free Period at 7 Days | 6 days |
| Oral Acetaminophen/Caffeine Group | Duration of Headache Free Period at 7 Days | 1 days |
p-value: 0.13Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days | 9 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days | 4 Participants |
p-value: 0.18Fisher Exact
Secondary
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days | 7 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days | 2 Participants |
p-value: 0.14Fisher Exact
Secondary
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Other: Pain at injection site
Time frame: 7 days
Population: Number of patients who responded to specific question at 7 day follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis) | 0 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis) | 2 Participants |
p-value: 0.23Fisher Exact
Secondary
Number of Participants With Need for Admission for Treatment of Headache
Time frame: 7 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Need for Admission for Treatment of Headache | 0 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Need for Admission for Treatment of Headache | 0 Participants |
Secondary
Number of Participants With Need for Crossover Treatment
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Need for Crossover Treatment | 9 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Need for Crossover Treatment | 14 Participants |
p-value: 0.19Chi-squared
Secondary
Number of Participants With Need for Neurology Consult
Time frame: 5 hours
Population: Patients with a refractory headache. Refractory headache = VRS score of \>3 2 hours after second-line treatment. This prompted Neurology consultation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Need for Neurology Consult | 4 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Need for Neurology Consult | 2 Participants |
p-value: 0.43Fisher Exact
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
Time frame: 28 days
Population: Patients who responded to specific question at 28 day follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Need for Representation for Treatment of Headache With 28 Days | 5 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Need for Representation for Treatment of Headache With 28 Days | 1 Participants |
p-value: 0.19Fisher Exact
Secondary
Number of Participants With Need for Second Line Treatment
Time frame: 120 min
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occipital Nerve Block | Number of Participants With Need for Second Line Treatment | 5 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Need for Second Line Treatment | 5 Participants |
p-value: 1Fisher Exact
Secondary
Number of Participants With Satisfaction of Response Treatment at 7 Days
Time frame: 7 days
Population: Patients who responded to specific question at 7 day follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Occipital Nerve Block | Number of Participants With Satisfaction of Response Treatment at 7 Days | Satisfied | 5 Participants |
| Occipital Nerve Block | Number of Participants With Satisfaction of Response Treatment at 7 Days | Dissatisfied | 1 Participants |
| Occipital Nerve Block | Number of Participants With Satisfaction of Response Treatment at 7 Days | Neutral | 3 Participants |
| Occipital Nerve Block | Number of Participants With Satisfaction of Response Treatment at 7 Days | Very dissatisfied | 2 Participants |
| Occipital Nerve Block | Number of Participants With Satisfaction of Response Treatment at 7 Days | Strongly satisfied | 12 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Satisfaction of Response Treatment at 7 Days | Very dissatisfied | 3 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Satisfaction of Response Treatment at 7 Days | Strongly satisfied | 10 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Satisfaction of Response Treatment at 7 Days | Satisfied | 4 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Satisfaction of Response Treatment at 7 Days | Neutral | 5 Participants |
| Oral Acetaminophen/Caffeine Group | Number of Participants With Satisfaction of Response Treatment at 7 Days | Dissatisfied | 1 Participants |
p-value: 0.92Fisher Exact
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.
Time frame: 60 min
Population: Patients who received crossover treatment. 2 patients in the ONB did not receive crossover as they were with drawn from the study due to decision for delivery. 1 patient in the SC group declined crossover.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Occipital Nerve Block | Response to Cross Over Treatment at 60 Min | 6 score on a scale |
| Oral Acetaminophen/Caffeine Group | Response to Cross Over Treatment at 60 Min | 3 score on a scale |
p-value: 0.028Wilcoxon (Mann-Whitney)
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.
Time frame: 180min
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Occipital Nerve Block | Response to Second Line Treatment at 60 Min | 6 score on a scale |
| Oral Acetaminophen/Caffeine Group | Response to Second Line Treatment at 60 Min | 4 score on a scale |
p-value: 0.61Wilcoxon (Mann-Whitney)
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.
Time frame: 2 hrs
Population: If headache was significantly improved at 1 hour, patient could leave prior to VRS at 2 hours (n=28 total patients). One patient was delivered following ONB instead of discharged due to decision for delivery prior to VRS at 2 hrs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Occipital Nerve Block | Response to Treatment Within 2 Hours | 6.0 score on a scale |
| Oral Acetaminophen/Caffeine Group | Response to Treatment Within 2 Hours | 6.5 score on a scale |
p-value: >0.99Wilcoxon (Mann-Whitney)