NCT05301387

The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Adult patients with postdural puncture headache was enrolled in main study (NCT03652714). In the main study the patients was randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl). Following inclusion in the main study all participants are sent a follow-up questionnaire. Primary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 months following initial block and average pain score in the 3 months following the initial block on a 0-10 pain intensity scale. Secondary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 previous months as well as average pain scores in the previous 3 months, days with headache and long and short term side effects of the block.

Conditions

• Post-Dural Puncture Headache
• Ganglion Sphenopalatine Block

Interventions

Type	Name	Description
PROCEDURE	Ganglion Sphenopalatine Block	Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL or Block performed with bilaterally inserted q-tips with isotone NaCl

Timeline

• Start date: 2021-11-26
• Primary completion: 2022-04-19
• Completion: 2022-04-19
• First posted: 2022-03-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: Denmark