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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02984618

Enrollment

Registered

2016-12-07

Start date

2016-12-01

Completion date

2019-12-20

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

Brief summary

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.

Interventions

PROCEDURESphenopalatine ganglion block

Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.

PROCEDUREEpidural blood patch

Autologous sterile blood (20ml) will be infused in the lombar epidural space.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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.

Other

Measure	Time frame	Description
Pain relief survival	Incidence of new headache onset during the first two weeks	Patients will be contacted for the first two weeks for monitoring new headache onsets.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026