HeadachePhase 4NCT03951649
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
A Phase 4 study testing Occipital Nerve Block in people with Headache and Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Headache, Pregnancy Related, Occipital Nerve Block
- What is being tested?
- Occipital Nerve Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Women and Infants center at the University of Alabama Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Headache, Pregnancy Related, Occipital Nerve Block
- Being tested
- Occipital Nerve Block
- Keywords
- headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block
- Medical subject headings
- Headache, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital Nerve BlockDrug
Also called Acetaminophen/Caffeine
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.
| Study group | Role | What they receive |
|---|---|---|
| Occipital Nerve block | Experimental | 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. Receives: Drug: Occipital Nerve Block |
| Oral Acetaminophen/Caffeine Group | Active comparator | Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache) Receives: Drug: Occipital Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60-300 min
Secondary outcomes (13)
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.
Measured: 2 hrs
Number of Participants With Need for Crossover Treatment
Measured: 4 hours
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.
Measured: 60 min
Number of Participants With Need for Second Line Treatment
Measured: 120 min
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.
Measured: 180min
Number of Participants With Need for Neurology Consult
Measured: 5 hours
Number of Participants With Need for Admission for Treatment of Headache
Measured: 7 hours
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
Measured: 28 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
Measured: 28 days
Number of Participants With Satisfaction of Response Treatment at 7 Days
Measured: 7 days
Duration of Headache Free Period at 7 Days
Measured: 7 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
Measured: 7 days
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Other: Pain at injection site
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start10 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trail
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Sinkey, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951649
- Sponsor's protocol ID
- HA123456789
- Status last verified
- Nov 2023
- First submitted
- 14 May 2019
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1941010Lipton 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.
PubMed 17261680Scharff L, Marcus DA, Turk DC. Headache during pregnancy and in the postpartum: a prospective study. Headache. 1997 Apr;37(4):203-10. doi: 10.1046/j.1526-4610.1997.3704203.x.
PubMed 9150614Bushman ET, Varner MW, Digre KB. Headaches Through a Woman's Life. Obstet Gynecol Surv. 2018 Mar;73(3):161-173. doi: 10.1097/OGX.0000000000000540.
PubMed 29595872Robbins MS, Farmakidis C, Dayal AK, Lipton RB. Acute headache diagnosis in pregnant women: a hospital-based study. Neurology. 2015 Sep 22;85(12):1024-30. doi: 10.1212/WNL.0000000000001954. Epub 2015 Aug 19.
PubMed 26291282Loder E, Biondi D. General principles of migraine management: the changing role of prevention. Headache. 2005 Apr;45 Suppl 1:S33-47. doi: 10.1111/j.1526-4610.2005.4501002.x.
PubMed 15833089Cuadrado 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.
PubMed 27296456Dach F, Eckeli AL, Ferreira Kdos S, Speciali JG. Nerve block for the treatment of headaches and cranial neuralgias - a practical approach. Headache. 2015 Feb;55 Suppl 1:59-71. doi: 10.1111/head.12516. Epub 2015 Feb 3.
PubMed 25644836Gul HL, Ozon AO, Karadas O, Koc G, Inan LE. The efficacy of greater occipital nerve blockade in chronic migraine: A placebo-controlled study. Acta Neurol Scand. 2017 Aug;136(2):138-144. doi: 10.1111/ane.12716. Epub 2016 Dec 2.
PubMed 27910088Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
PubMed 27901275Tang 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.
PubMed 28844531Tobin J, Flitman S. Occipital nerve blocks: when and what to inject? Headache. 2009 Nov-Dec;49(10):1521-33. doi: 10.1111/j.1526-4610.2009.01493.x. Epub 2009 Aug 6.
PubMed 19674126Blumenfeld A, Ashkenazi A, Napchan U, Bender SD, Klein BC, Berliner R, Ailani J, Schim J, Friedman DI, Charleston L 4th, Young WB, Robertson CE, Dodick DW, Silberstein SD, Robbins MS. Expert consensus recommendations for the performance of peripheral nerve blocks for headaches--a narrative review. Headache. 2013 Mar;53(3):437-46. doi: 10.1111/head.12053. Epub 2013 Feb 13.
PubMed 23406160Voigt 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.
PubMed 25440865Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.
PubMed 25415168
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03951649
- Acronym / sponsor ID
- HA123456789
- Conditions
- Headache, Pregnancy Related, Occipital Nerve Block
- Keywords
- headache, Pregnancy, Acute treatment, Emergency department, Occipital nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled Trail
| Arm | Type | Receives |
|---|---|---|
| Occipital Nerve block | Experimental | Drug: Occipital Nerve Block1. 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. |
| Oral Acetaminophen/Caffeine Group | Active comparator | Drug: Occipital Nerve BlockAcetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache) |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital Nerve BlockAlso: Acetaminophen/CaffeineThis 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. | Drug | Occipital Nerve block, Oral Acetaminophen/Caffeine Group |
Primary outcome
Number of Participants With Response to Occipital Nerve Block in Pregnancy
Time frame: 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.
13 secondary outcomes
Response to Treatment Within 2 Hours
Time frame: 2 hrs
Number of Participants With Need for Crossover Treatment
Time frame: 4 hours
Response to Cross Over Treatment at 60 Min
Time frame: 60 min
Number of Participants With Need for Second Line Treatment
Time frame: 120 min
Response to Second Line Treatment at 60 Min
Time frame: 180min
Number of Participants With Need for Neurology Consult
Time frame: 5 hours
Number of Participants With Need for Admission for Treatment of Headache
Time frame: 7 hours
Number of Participants With Need for Representation for Treatment of Headache With 28 Days
Time frame: 28 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
Time frame: 28 days
Number of Participants With Satisfaction of Response Treatment at 7 Days
Time frame: 7 days
Duration of Headache Free Period at 7 Days
Time frame: 7 days
Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
Time frame: 7 days
Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1941010Rasmussen 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.
- Background: PubMed 17261680Lipton 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.
- Background: PubMed 9150614Scharff L, Marcus DA, Turk DC. Headache during pregnancy and in the postpartum: a prospective study. Headache. 1997 Apr;37(4):203-10. doi: 10.1046/j.1526-4610.1997.3704203.x.
- Background: PubMed 29595872Bushman ET, Varner MW, Digre KB. Headaches Through a Woman's Life. Obstet Gynecol Surv. 2018 Mar;73(3):161-173. doi: 10.1097/OGX.0000000000000540.
- Background: PubMed 26291282Robbins MS, Farmakidis C, Dayal AK, Lipton RB. Acute headache diagnosis in pregnant women: a hospital-based study. Neurology. 2015 Sep 22;85(12):1024-30. doi: 10.1212/WNL.0000000000001954. Epub 2015 Aug 19.
- Background: PubMed 15833089Loder E, Biondi D. General principles of migraine management: the changing role of prevention. Headache. 2005 Apr;45 Suppl 1:S33-47. doi: 10.1111/j.1526-4610.2005.4501002.x.
- Background: PubMed 27296456Cuadrado 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.
- Background: PubMed 25644836Dach F, Eckeli AL, Ferreira Kdos S, Speciali JG. Nerve block for the treatment of headaches and cranial neuralgias - a practical approach. Headache. 2015 Feb;55 Suppl 1:59-71. doi: 10.1111/head.12516. Epub 2015 Feb 3.
- Background: PubMed 27910088Gul HL, Ozon AO, Karadas O, Koc G, Inan LE. The efficacy of greater occipital nerve blockade in chronic migraine: A placebo-controlled study. Acta Neurol Scand. 2017 Aug;136(2):138-144. doi: 10.1111/ane.12716. Epub 2016 Dec 2.
- Background: PubMed 27901275Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
- Background: PubMed 28844531Tang 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.
- Background: PubMed 19674126Tobin J, Flitman S. Occipital nerve blocks: when and what to inject? Headache. 2009 Nov-Dec;49(10):1521-33. doi: 10.1111/j.1526-4610.2009.01493.x. Epub 2009 Aug 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Occipital Nerve Block in people with Headache and Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Response to Occipital Nerve Block in Pregnancy (time frame: 60-300 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951649, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.