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Main study concluded before enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthetic | Experimental |
| |
| Isotonic NaCl | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 | Procedure | Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Copenhagen | 2400 | Denmark | |||
| Rigshospitalet, University of Copenhagen |
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| Ganglion sphenopalatine block with placebo administered on study GSPB-2018 | Procedure | Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018. |
|
| Copenhagen |
| Denmark |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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