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The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthetic | Experimental |
| |
| Isotonic NaCl | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganglion sphenopalatine block with local anesthetic | Procedure | Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position. | 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. | 30 minutes after block |
| Measure | Description | Time Frame |
|---|---|---|
| Pain rating (0-100mm on a visual analogue scale, VAS) in standing position | 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. | 1 hour after block and 1 week after block |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, University of Copenhagen | Copenhagen | 2100 | Denmark | |||
| Bispebjerg and Frederiksberg Hospital, University of Copenhagen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303377 | Derived | 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. |
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| Ganglion sphenopalatine block with placebo | Procedure | Block performed with bilaterally inserted q-tips with isotone NaCl |
|
| Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS) |
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. |
| 30 minutes after block |
| 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 |
| Copenhagen |
| 2400 |
| Denmark |
| Rigshospitalet Glostrup, University of Copenhagen | Glostrup Municipality | 2600 | Denmark |
| Herlev Hospital, University of Copenhagen | Herlev | 2730 | Denmark |
| Nordsjællands Hospital Hillerød | Hillerød | 3400 | Denmark |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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