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The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial

Clinical Trial Summary

The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.

Clinical Trial Description

Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.

If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03652714
Study type Interventional
Source University Hospital Bispebjerg and Frederiksberg
Contact
Status Completed
Phase Phase 3
Start date September 19, 2018
Completion date September 9, 2019
View Details
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