An observational study in Post-Dural Puncture Headache and Ganglion Sphenopalatine Block, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational
The purpose of this study is to evaluate the long term effects of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
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.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
This study's enrollment of 38 is below the median of 44 across 28 observational studies indexed under Ganglion Cysts.
Browse Ganglion Cysts studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
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Patients who were included in main study NCT03652714
Patients who where included in main study and had the following eligibility criteria:
Inclusion Criteria:
Exclusion Criteria:
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
Migraine Disability Assessment Test score
Disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test Score (MIDAS) ranging from no disability at a score of 0 to severe disability at a score of 21+
Time frame: 3 months following initial block
Average pain score
Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.
Time frame: 3 months following initial block
Migraine Disability Assessment Test score
Disability due to headache is defined as moderate to severe disability measured with Migraine Disability Assessment Test Score (MIDAS) ranging from no disability at a score of 0 to severe disability at a score of 21+
Time frame: 3 previous months
Average pain score
Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.
Time frame: 3 previous months
Days with headache
Number of days with headache
Time frame: 3 months following initial block as well as the last 3 months
Short term side effects
Side effects following the block are defined as side effects with a duration of less than 3 months
Time frame: From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.
Long term side effects
Side effects following the block defined as side effects with a duration of more than 3 months
Time frame: From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Bispebjerg and Frederiksberg