Clinical trial NCT03652714: The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache
Official title: The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postdural Puncture Headache
Sphenopalatine Ganglion Block
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.

Detailed description: Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.

If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS \<30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.

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: Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
timeFrame: 30 minutes after block
Secondary outcomes:
measure: Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
timeFrame: 1 hour after block and 1 week after block
measure: Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
timeFrame: 30 minutes after block
measure: Number of patients needing "rescue GSP-block"
timeFrame: During study period until completion of 1 week follow up
measure: Number of patients needing a epidural blood patch
timeFrame: During study period until completion of 1 week follow up
measure: Pain rating (0-100mm on a visual analogue scale, VAS) in supine position
timeFrame: 30 minutes after block, 1 hour after block and 1 week after block
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, University of Copenhagen
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup, University of Copenhagen
city: Herlev
country: Denmark
facility: Herlev Hospital, University of Copenhagen
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital Hillerød
Study officials:
References:
citation: Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.