Clinical trial NCT05301387: The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up
Official title: The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Dural Puncture Headache
Ganglion Sphenopalatine Block
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were included in main study NCT03652714

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.

Eligibility 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

Primary outcomes:
measure: Migraine Disability Assessment Test score
timeFrame: 3 months following initial block
measure: Average pain score
timeFrame: 3 months following initial block
Secondary outcomes:
measure: Migraine Disability Assessment Test score
timeFrame: 3 previous months
measure: Average pain score
timeFrame: 3 previous months
measure: Days with headache
timeFrame: 3 months following initial block as well as the last 3 months
measure: Short term side effects
timeFrame: From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.
measure: Long term side effects
timeFrame: From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Study officials:
References: