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
NCT ID: NCT03966547
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-05-31
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Local anesthetic
Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.
Isotonic NaCl
Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.
Interventions
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Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
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-2018
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Mads Seit Jespersen
Medical Doctor, Primary Investigator
Locations
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Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, , Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Countries
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Other Identifiers
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GSPB-2018-SUB
Identifier Type: -
Identifier Source: org_study_id