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

Postdural Puncture Headache Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03966547
• Other study ID #: GSPB-2018-SUB
• Status: Withdrawn
• Phase: N/A
• Start date: May 2020
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache
• Sphenopalatine Ganglion Block

Intervention

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.
• Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital, University of Copenhagen	Copenhagen
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	<1h before and 1 hour after each intervention
Primary	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.	<1h before and 1 hour after each intervention
Secondary	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.	<1h before and 1 hour after each intervention