Acute Headache Treatment in Pregnancy: Occipital Nerve Bl... | NCT03951649

Acute Headache Treatment in Pregnancy: Occipital Nerve Bl... | NCT03951649 | Trialant

Description Module

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).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Occipital Nerve block	Experimental	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.	Drug: Occipital Nerve Block
Oral Acetaminophen/Caffeine Group	Active Comparator	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)	Drug: Occipital Nerve Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occipital Nerve Block	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
The Women and Infants center at the University of Alabama Birmingham		Birmingham	Alabama	35233	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1941010	Background	Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. doi: 10.1016/0895-4356(91)90147-2.
17261680	Background	Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.

Arm/Group Information

ID	Title	Description
FG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
FG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00031 subjects FG00131 subjects
COMPLETED		FG00031 subjects FG00131 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Count of Participants

Participants

60-300 min

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pre-term Birth	Pregnancy, puerperium and perinatal conditions		Systematic Assessment	PTB, Sev SiPreE, not related to study

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Rachel Sinkey	UAB	(205) 934-5611		rsinkey@uabmc.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 15, 2019	Sep 27, 2023	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D006261	Headache
D004630	Emergencies

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D000082	Acetaminophen
D002110	Caffeine

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Black, Non-Hispanic	BG00015 BG00122 BG00237
Hispanic	BG0002 BG0013 BG0025
White, Non-Hispanic	BG00014 BG0016 BG00220

Known primary headache disorder

Count of Participants

Participants

Title

Denominators

Categories

Overall

Title	Measurements
	BG0009 BG00114 BG00223

Migraine

Title	Measurements
	BG0008 BG00112 BG00220

Tension

Title	Measurements
	BG0001 BG0012 BG0023

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.30														Superiority

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.

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.

Posted

Median

Inter-Quartile Range

score on a scale

2 hrs

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00013 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0006.0(4.0 to 8.0) OG0016.5(2.5 to 8.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		>0.99	The p-value was calculated using a 2 sided Wilcoxon rank sum test.													Superiority

Secondary

Number of Participants With Need for Crossover Treatment

Posted

Count of Participants

Participants

4 hours

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0009 OG00114

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.19														Superiority

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.

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.

Posted

Median

Inter-Quartile Range

score on a scale

60 min

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG0009 OG00114

Title

Denominators

Categories

Title	Measurements
	OG0006(4 to 8) OG0013(0 to 4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.028														Superiority

Secondary

Number of Participants With Need for Second Line Treatment

Posted

Count of Participants

Participants

120 min

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0015

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		1.00	P-value was calculated													Superiority

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.

Posted

Median

Inter-Quartile Range

score on a scale

180min

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG0005 OG0015

Title

Denominators

Categories

Title	Measurements
	OG0006(4 to 7) OG0014(3 to 5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.61														Superiority

Secondary

Number of Participants With Need for Neurology Consult

Patients with a refractory headache. Refractory headache = VRS score of >3 2 hours after second-line treatment. This prompted Neurology consultation.

Posted

Count of Participants

Participants

5 hours

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG0004 OG0013

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0012

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.43														Superiority

Secondary

Number of Participants With Need for Admission for Treatment of Headache

Posted

Count of Participants

Participants

7 hours

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

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

Patients who responded to specific question at 28 day follow up.

Posted

Count of Participants

Participants

28 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00024 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0011

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.19														Superiority

Secondary

Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days

Posted

Count of Participants

Participants

28 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0009 OG0014

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.18														Superiority

Secondary

Number of Participants With Satisfaction of Response Treatment at 7 Days

Patients who responded to specific question at 7 day follow up.

Posted

Count of Participants

Participants

7 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00023 OG00123

Title

Denominators

Categories

Title	Measurements
Strongly satisfied	OG00012 OG00110
Satisfied	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.92														Superiority

Secondary

Duration of Headache Free Period at 7 Days

Patients who responded to specific question at 7 day follow up.

Posted

Median

Inter-Quartile Range

days

7 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00014 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0006(0.5 to 7) OG0011(0 to 5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.13														Superiority

Secondary

Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days

Posted

Count of Participants

Participants

7 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0007 OG0012

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.14														Superiority

Secondary

Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)

Other: Pain at injection site

Number of patients who responded to specific question at 7 day follow up.

Posted

Count of Participants

Participants

7 days

ID	Title	Description
OG000	Occipital Nerve Block	Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks. Site of injection will be cleaned with an alcohol swab. 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. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
OG001	Oral Acetaminophen/Caffeine Group	Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)

Units	Counts
Participants	OG00024 OG00123

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0012

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher Exact		0.23														Superiority