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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

Primary Purpose

Postdural Puncture Headache, Sphenopalatine Ganglion Block

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Sponsored by
University Hospital Bispebjerg and Frederiksberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postdural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bispebjerg and Frederiksberg Hospital, University of Copenhagen
  • Rigshospitalet, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Local anesthetic

Isotonic NaCl

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 14, 2019
Last Updated
November 18, 2020
Sponsor
University Hospital Bispebjerg and Frederiksberg
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1. Study Identification

Unique Protocol Identification Number
NCT03966547
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Main study concluded before enrollment
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Bispebjerg and Frederiksberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Sphenopalatine Ganglion Block

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthetic
Arm Type
Experimental
Arm Title
Isotonic NaCl
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
Intervention Description
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.
Intervention Type
Procedure
Intervention Name(s)
Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Intervention Description
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.
Primary Outcome Measure Information:
Title
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.
Description
Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment.
Time Frame
<1h before and 1 hour after each intervention
Title
Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.
Description
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.
Time Frame
<1h before and 1 hour after each intervention
Secondary Outcome Measure Information:
Title
Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.
Description
Changes in mean, minimum and maximum Cerebral Blood Flow velocity in cm/sec (CBF) before and after treatment.
Time Frame
<1h before and 1 hour after each intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Rigshospitalet, University of Copenhagen
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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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