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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed 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 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.
Sponsor: Brasilia University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Pain relief [ Time Frame: Pain reduction to no pain or low pain within 30 minutes of the intervention. ]

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


Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome: Same as current

Information By: Brasilia University Hospital

Dates:
Date Received: December 3, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: December 12, 2016
Last Verified: December 2016