Postdural Puncture HeadacheNCT03966547
Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
A study testing Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
Trial summary
The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postdural Puncture Headache, Sphenopalatine Ganglion Block
- What is being tested?
- Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
- Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
- Patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations.
Who cannot join
- Patients who cannot cooperate to the study
- Patients who does not understand or speak Danish
- Allergy to the drugs used in the study
- Has taken opioids within 12 hours prior to intervention
- No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, 2400
Rigshospitalet, University of Copenhagen
Copenhagen
About this study
The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.
- Being tested
- Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018, Ganglion sphenopalatine block with placebo administered on study GSPB-2018
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018Procedure or surgery
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.
Ganglion sphenopalatine block with placebo administered on study GSPB-2018Procedure or surgery
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic | Experimental | Not described Receives: Procedure: Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 |
| Isotonic NaCl | Placebo comparator | Not described Receives: Procedure: Ganglion sphenopalatine block with placebo administered on study GSPB-2018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.
Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment.
Measured: <1h before and 1 hour after each intervention
Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
Pain intensity measured with a pain rating (0-100mm on a visual analogue scale, VAS) in supine position and as worst experienced pain after the patient has been upright for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
Cerebral Blood Flow velocity (CBF) measured as mean blood flow in cm/sec.
Measured: <1h before and 1 hour after each intervention
Secondary outcomes (1)
Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.
Changes in mean, minimum and maximum Cerebral Blood Flow velocity in cm/sec (CBF) before and after treatment.
Measured: <1h before and 1 hour after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study startMay 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Main study concluded before enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966547
- Sponsor's protocol ID
- GSPB-2018-SUB
- Status last verified
- Nov 2020
- First submitted
- 14 May 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
- ClinicalTrials.gov ID
- NCT03966547
- Acronym / sponsor ID
- GSPB-2018-SUB
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Main study concluded before enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic | Experimental | Procedure: Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 |
| Isotonic NaCl | Placebo comparator | Procedure: Ganglion sphenopalatine block with placebo administered on study GSPB-2018 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
- Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
- Patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations.
Key exclusion criteria (5 listed)
- Patients who cannot cooperate to the study
- Patients who does not understand or speak Danish
- Allergy to the drugs used in the study
- Has taken opioids within 12 hours prior to intervention
- No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.
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 |
|---|---|---|
| Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018. | Procedure or surgery | Local anesthetic |
| Ganglion sphenopalatine block with placebo administered on study GSPB-2018Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018. | Procedure or surgery | Isotonic NaCl |
Primary outcome
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.
Time frame: <1h before and 1 hour after each intervention
Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment.
Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
Time frame: <1h before and 1 hour after each intervention
Pain intensity measured with a pain rating (0-100mm on a visual analogue scale, VAS) in supine position and as worst experienced pain after the patient has been upright for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. Cerebral Blood Flow velocity (CBF) measured as mean blood flow in cm/sec.
1 secondary outcome
Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.
Time frame: <1h before and 1 hour after each intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 in people with Postdural Puncture Headache and Sphenopalatine Ganglion Block, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.
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 5 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: withdrawn, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment. (time frame: <1h before and 1 hour after each intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2020.