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.
Study Type
OBSERVATIONAL
Enrollment
38
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
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, Denmark
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
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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.