Postdural Puncture Headache, Sphenopalatine Ganglion Block
Conditions
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.
Interventions
PROCEDUREGanglion sphenopalatine block with local anesthetic
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
PROCEDUREGanglion sphenopalatine block with placebo
Block performed with bilaterally inserted q-tips with isotone NaCl
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 |
|---|---|---|
| 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 | Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain rating (0-100mm on a visual analogue scale, VAS) in standing position | 1 hour after block and 1 week after block | Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. |
| Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS) | 30 minutes after block | Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. |
| Number of patients needing rescue GSP-block | During study period until completion of 1 week follow up | — |
| Number of patients needing a epidural blood patch | During study period until completion of 1 week follow up | — |
| Pain rating (0-100mm on a visual analogue scale, VAS) in supine position | 30 minutes after block, 1 hour after block and 1 week after block | — |
Countries
Denmark
Outcome results
None listed