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

February 26, 2020 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70000000
        • Hospital Universitario de Brasilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side
Procedure: Sphenopalatine ganglion block
Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
Active Comparator: Control group
Patients will receive classic epidural blood patch with 20ml of autologous blood
Procedure: Epidural blood patch
Autologous sterile blood (20ml) will be infused in the lombar epidural space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 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.
Pain reduction to no pain or low pain within 30 minutes of the intervention.

Secondary Outcome Measures

Outcome Measure
Time Frame
Tinitus
Time Frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Low back pain
Time Frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Sore throat
Time Frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Incidence (dichotomic) of sore throat within 24 hours after the procedure.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Investigators

  • Principal Investigator: Gabriel MN Guimaraes, MsC, MD, Universidade de Brasília

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

December 3, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 60693416.0.0000.5558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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