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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Dural Puncture Headache, Ganglion Sphenopalatine Block

Intervention / Treatment
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* Procedure: Ganglion Sphenopalatine Block


Participation Criteria
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Eligibility Criteria
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Patients who where included in main study and had the following eligibility criteria: Inclusion Criteria: Age > 18 years Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture. Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations. Exclusion Criteria: Patients who cannot cooperate to the study Patients who does not understand or speak Danish Allergy to the drugs used in the study Has taken opioids within 12 hours prior to intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |