Ganglion Sphenopalatine Block, Post-Dural Puncture Headache
Conditions
Brief 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.
Interventions
PROCEDUREGanglion 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
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Disability Assessment Test score | 3 months following initial block | 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+ |
| Average pain score | 3 months following initial block | Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days with headache | 3 months following initial block as well as the last 3 months | Number of days with headache |
| Migraine Disability Assessment Test score | 3 previous months | 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+ |
| Long term side effects | From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months. | Side effects following the block defined as side effects with a duration of more than 3 months |
| Short term side effects | From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months. | Side effects following the block are defined as side effects with a duration of less than 3 months |
| Average pain score | 3 previous months | Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable. |
Countries
Denmark
Outcome results
None listed