ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02984618
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Procedure: Sphenopalatine ganglion block Procedure: Epidural blood patch Phase 3

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  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gabriel Guimaraes: Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Tinitus [ Time Frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure. ]
  2. Low back pain [ Time Frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure. ]
  3. Sore throat [ Time Frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure. ]

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984618


Contacts
Contact: Gabriel MN Guimaraes, Md, Msc +5561996455997 gabrielmng@gmail.com

Locations
Brazil
Hospital Universitário de Brasilia Recruiting
Brasilia, Distrito Federal, Brazil, 70000000
Contact: Gabriel MN Guimarães, MD, MsC    +5561996455997    gabrielmng@gmail.com   
Principal Investigator: Gabriel MN Guimarães, Md, MSc         
Sponsors and Collaborators
Brasilia University Hospital
Investigators
Principal Investigator: Gabriel MN Guimaraes, MsC, MD Universidade de Brasilia

Responsible Party: Gabriel Magalhaes Nunes Guimaraes, Substitute professor of Anesthesiology, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT02984618     History of Changes
Other Study ID Numbers: CAAE: 60693416.0.0000.5558
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases