Clinical Trial: Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

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

Official Title: A Comparison of the Efficacy of Sphenopalatine Ganglion (SPG) Block With 5% Lidocaine Versus Epidural Blood Patch (EBP) for the Treatment of Post-Dural Puncture Headache (PDPH)

Brief Summary: The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

Detailed Summary: The sphenopalitine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalitine nerve block will help the patient with the headache.
Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome:

  • Pain Questionnaire prior to initiation of either therapy [ Time Frame: Prior to initiation of therapy (Epidural blood patch vs Sphenopalatine Ganglion Block). ]
    Outcome measure will entail recording patient self-reported pain scores to quantify the level of headache pain using the Visual analog scale, meaning 0 - No pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-10 - Severe Pain, by way of in person assessment by pain questionnaire just prior to initiation of either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
  • Pain Questionnaire at 30 minutes following either therapy. [ Time Frame: At 30 minutes following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin the description of outcome 1 above) by way of in person assessment by pain questionnaire at 30 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
  • Pain Questionnaire at 60 minutes following either therapy. [ Time Frame: At 60 minutes following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using the Visual analog scale (as defined withinin the description of outcome 1 above) by way of in person assessment by pain questionnaire at 60 minutes following either therapy (Epidural blood patch vs Sphenopalatine Ganglion Block).
  • Pain Questionnaire at 24 hours following either therapy. [ Time Frame: At 24 hours following either therapy. ]
    Self-reported pain scores to quantify the level of headache pain using t

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Rutgers, The State University of New Jersey

    Dates:
    Date Received: September 3, 2014
    Date Started: September 2016
    Date Completion: July 2025
    Last Updated: April 7, 2017
    Last Verified: April 2017