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

Brasilia University Hospital

Status: Terminated

Conditions: Post-Dural Puncture Headache

Treatments: Procedure: Sphenopalatine ganglion block; Procedure: Epidural blood patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02984618

CAAE: 60693416.0.0000.5558

Details and patient eligibility

About

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

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side

Treatment:

Procedure: Sphenopalatine ganglion block

Control group

Active Comparator group

Description:

Patients will receive classic epidural blood patch with 20ml of autologous blood

Treatment:

Procedure: Epidural blood patch