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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

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ClinicalTrials.gov Identifier: NCT03966547
Recruitment Status : Withdrawn (Main study concluded before enrollment)
First Posted : May 29, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg

Brief 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.

Condition or disease Intervention/treatment Phase
Postdural Puncture Headache Sphenopalatine Ganglion Block Procedure: Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 Procedure: Ganglion sphenopalatine block with placebo administered on study GSPB-2018 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Local anesthetic Procedure: 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.

Placebo Comparator: Isotonic NaCl Procedure: Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions. [ Time Frame: <1h before and 1 hour after each intervention ]
    Changes in mean, minimum and maximum Cerebral Blood Flow velocity in cm/sec (CBF) before and after treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study Population:

Subjects who have consented to participate in GSPB-2018 will be approached for participation in this sub-study. Subjects who have consented to participate in GSPB-2018 are not required to participate in this sub-study.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966547


Locations
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Denmark
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, Denmark, 2400
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
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Responsible Party: Mads Seit Jespersen, Medical Doctor, Primary Investigator, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT03966547    
Other Study ID Numbers: GSPB-2018-SUB
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents