The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Postdural Puncture Headache
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Mads Seit Jespersen
MD
University Hospital Bispebjerg and Frederiksberg
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
Outcomes
Primary Outcomes
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
Time Frame: 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 Outcomes
- Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)(30 minutes after block)
- Number of patients needing "rescue GSP-block"(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)
- Pain rating (0-100mm on a visual analogue scale, VAS) in standing position(1 hour after block and 1 week after block)
- Number of patients needing a epidural blood patch(During study period until completion of 1 week follow up)