Clinical trial NCT02427009: Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Official title: Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Dural Puncture Headache
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The patient has signed the informed consent
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is available for follow up concerning her hospital stay
* The patient has a post-dural puncture headache after a vaginal delivery. The diagnosis of post-puncture headache is retained on the basis of a frankly postural character for the headache, triggered or exacerbated by orthostatic position and relieved by recumbency.
* The patient has an indication for a blood patch

Exclusion Criteria:

* The patient is participating in another interventional study, with the exception of the following studies: Papillo PMA (2013-A00538-37); DG-Postpartum (2013-A00277-38); ElastoMAP (2013-A01148-37); ElastoDéclench (2014-A00828-39); LXRs(2009-A00968-49); OASIS II (2013-A00773-42); GrossPath (2014-A01120-47).
* The patient is in an exclusion period determined by a previous study
* The patient is under guardianship, curatorship or under judicial protection
* The patient refuses to sign the consent
* It is not possible correctly inform the patient
* The patient is pregnant
* The patient has a contra-indication (or an incompatible combination therapy) for a necessary treatment in this study
* The patient was delivered by cesarean section

Primary outcomes:
measure: Headache recurrence: yes/no
timeFrame: 24 hours after first blood patch
measure: Headache recurrence: yes/no
timeFrame: 48 hours after first blood patch
measure: Headache recurrence: yes/no
timeFrame: 72 hours after first blood patch
Secondary outcomes:
measure: The number of blood patches required for each patient
timeFrame: Hospital discharge (expected average of 7 days)
measure: Visual analog scale for pain
timeFrame: Baseline (day 0)
measure: Visual analog scale for pain
timeFrame: 24 hours after blood patch
measure: Visual analog scale for pain
timeFrame: 48 hours after blood patch
measure: Visual analog scale for pain
timeFrame: 72 hours after blood patch
measure: Presence/absence of complications
timeFrame: During hospital stay (expected average of 7 days)
measure: 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.
timeFrame: During hospital stay (expected average of 7 days)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Guy Aya, MD
role: STUDY_DIRECTOR
References: