- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984618
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
-
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Distrito Federal
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Brasilia, Distrito Federal, Brazil, 70000000
- Hospital Universitário de Brasília
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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
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Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
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Active Comparator: Control group
Patients will receive classic epidural blood patch with 20ml of autologous blood
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Autologous sterile blood (20ml) will be infused in the lombar epidural space.
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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.
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Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.
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Pain reduction to no pain or low pain within 30 minutes of the intervention.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tinitus
Time Frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
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Incidence (dichotomic) of tinutus within 24 hours after the procedure.
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Low back pain
Time Frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
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Incidence (dichotomic) of low back pain within 24 hours after the procedure.
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Sore throat
Time Frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
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Incidence (dichotomic) of sore throat within 24 hours after the procedure.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain relief survival
Time Frame: Incidence of new headache onset during the first two weeks
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Patients will be contacted for the first two weeks for monitoring new headache onsets.
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Incidence of new headache onset during the first two weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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