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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganglion Sphenopalatine Block | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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+ | 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. | 3 months following initial block |
| Measure | Description | Time Frame |
|---|---|---|
| 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+ | 3 previous months |
| Average pain score |
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Patients who where included in main study and had the following eligibility criteria:
Inclusion Criteria:
Exclusion Criteria:
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Patients who were included in main study NCT03652714
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central 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 |
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Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable. |
| 3 previous months |
| Days with headache | Number of days with headache | 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 | 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 | From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months. |
| D009422 | Nervous System Diseases |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |