Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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 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.

Official Title
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Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial

Conditions
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Post-Dural Puncture Headache

Intervention / Treatment
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* Procedure: Sphenopalatine ganglion block
* Procedure: Epidural blood patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria for post dural puncture headache Moderate to severe post dural puncture headache Exclusion Criteria: Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs. Follow up loss

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side | Procedure: Sphenopalatine ganglion block<br>* Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.<br>|
| Active Comparator: Control group<br>Patients will receive classic epidural blood patch with 20ml of autologous blood | Procedure: Epidural blood patch<br>* Autologous sterile blood (20ml) will be infused in the lombar epidural space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| Sore throat |  | Incidence (dichotomic) of sore throat within 24 hours after the procedure. |