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High recurrence of headache in SPG group.
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Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side |
|
| Control group | Active Comparator | Patients will receive classic epidural blood patch with 20ml of autologous blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine ganglion block | Procedure | Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure. | Pain reduction to no pain or low pain within 30 minutes of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Tinitus | Incidence (dichotomic) of tinutus within 24 hours after the procedure. | |
| Low back pain | Incidence (dichotomic) of low back pain within 24 hours after the procedure. | |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief survival | Patients will be contacted for the first two weeks for monitoring new headache onsets. | Incidence of new headache onset during the first two weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel MN Guimaraes, MsC, MD | Universidade de Brasilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário de Brasilia | BrasÃlia | Federal District | 70000000 | Brazil |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D017217 | Blood Patch, Epidural |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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| Epidural blood patch | Procedure | Autologous sterile blood (20ml) will be infused in the lombar epidural space. |
|
| Sore throat |
| Incidence (dichotomic) of sore throat within 24 hours after the procedure. |
| D009422 | Nervous System Diseases |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |