Clinical Trial: Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

Brief Summary: The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.

Detailed Summary:

The secondary objectives of this study are to:

A. To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome:

  • Headache recurrence: yes/no [ Time Frame: 24 hours after first blood patch ]
    Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
  • Headache recurrence: yes/no [ Time Frame: 48 hours after first blood patch ]
    Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby
  • Headache recurrence: yes/no [ Time Frame: 72 hours after first blood patch ]
    Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of blood patches required for each patient [ Time Frame: Hospital discharge (expected average of 7 days) ]
  • Visual analog scale for pain [ Time Frame: Baseline (day 0) ]
    Scale from 0.0 to 10.0.
  • Visual analog scale for pain [ Time Frame: 24 hours after blood patch ]
    Scale from 0.0 to 10.0.
  • Visual analog scale for pain [ Time Frame: 48 hours after blood patch ]
    Scale from 0.0 to 10.0.
  • Visual analog scale for pain [ Time Frame: 72 hours after blood patch ]
    Scale from 0.0 to 10.0.
  • Presence/absence of complications [ Time Frame: During hospital stay (expected average of 7 days) ]
    Presence / absence of the following complications: nerve paresthesia; nerve damage; accidental dural puncture; subcutaneous hematoma at the puncture site; meningitis; epidural abscess; localized infection at the puncture site; encephalopathy; cerebral venous thrombosis; subdural hematoma
  • In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain. [ Time Frame: During hospital stay (expected average of 7 days) ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: April 20, 2015
Date Started: December 2015
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017