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

Post-Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02984618
• Other study ID #: CAAE: 60693416.0.0000.5558
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Procedure:
• Sphenopalatine ganglion block
Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
• Epidural blood patch
Autologous sterile blood (20ml) will be infused in the lombar epidural space.

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Tinitus		Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Secondary	Low back pain		Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Secondary	Sore throat		Incidence (dichotomic) of sore throat within 24 hours after the procedure.