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

Not Applicable

Terminated

• Conditions: Post-Dural Puncture Headache
• Interventions: Procedure: Epidural blood patch; Procedure: Sphenopalatine ganglion block

• Registration Number: NCT02984618
• Lead Sponsor: Brasilia University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2016-12-03
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-07
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Epidural blood patch	Patients will receive classic epidural blood patch with 20ml of autologous blood
Treatment group	Sphenopalatine ganglion block	Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side

Primary Outcome Measures

Name	Time	Method
Pain relief	Pain reduction to no pain or low pain within 30 minutes of the intervention.	Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.

Secondary Outcome Measures

Name	Time	Method
Tinitus	Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Sore throat	Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Low back pain	Incidence (dichotomic) of low back pain within 24 hours after the procedure.

Trial Locations

Locations (1)

Hospital Universitário de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil