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

Not Applicable

Withdrawn

• Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block

• Registration Number: NCT03966547
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Study Start: 2020-05
• Primary Completion: 2020-08
• Study Completion: 2020-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.	<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.
Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.	<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.

Secondary Outcome Measures

Name	Time	Method
Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.	<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.

Trial Locations

Locations (2)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark