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

Primary Purpose

Post-Dural Puncture Headache

Status

Terminated

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Sphenopalatine ganglion block

Epidural blood patch

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Universitário de Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain relief

Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.

Secondary Outcome Measures

Tinitus

Low back pain

Sore throat

Full Information

NCT ID

NCT02984618

First Posted

December 3, 2016

Last Updated

February 26, 2020

Sponsor

Brasilia University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02984618

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

High recurrence of headache in SPG group.

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

December 20, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brasilia University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Dural Puncture Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Sphenopalatine ganglion block

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Epidural blood patch

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain relief

Description

Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.

Time Frame

Pain reduction to no pain or low pain within 30 minutes of the intervention.

Secondary Outcome Measure Information:

Title

Tinitus

Time Frame

Incidence (dichotomic) of tinutus within 24 hours after the procedure.

Title

Low back pain

Time Frame

Incidence (dichotomic) of low back pain within 24 hours after the procedure.

Title

Sore throat

Time Frame

Incidence (dichotomic) of sore throat within 24 hours after the procedure.

Other Pre-specified Outcome Measures:

Title

Pain relief survival

Description

Patients will be contacted for the first two weeks for monitoring new headache onsets.

Time Frame

Incidence of new headache onset during the first two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriel MN Guimaraes, MsC, MD

Organizational Affiliation

Universidade de Brasilia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitário de Brasilia

City

Brasilia

State/Province

Distrito Federal

ZIP/Postal Code

70000000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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