Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02984618|
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Dural Puncture Headache||Procedure: Sphenopalatine ganglion block Procedure: Epidural blood patch||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Tinitus [ Time Frame: 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. ]
- Sore throat [ Time Frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure. ]
- 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.
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
|Contact: Gabriel MN Guimaraes, Md, Mscemail@example.com|
|Hospital Universitário de Brasilia||Recruiting|
|Brasilia, Distrito Federal, Brazil, 70000000|
|Contact: Gabriel MN Guimarães, MD, MsC +5561996455997 firstname.lastname@example.org|
|Principal Investigator: Gabriel MN Guimarães, Md, MSc|
|Principal Investigator:||Gabriel MN Guimaraes, MsC, MD||Universidade de Brasilia|