Post-Dural Puncture Headache
Conditions
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.
Interventions
OTHERProne position for 1 hour after blood patch
After performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization.
PROCEDUREBlood patch
And indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache recurrence: yes/no | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of blood patches required for each patient | Hospital discharge (expected average of 7 days) | — |
| Visual analog scale for pain | Baseline (day 0) | Scale from 0.0 to 10.0. |
| Presence/absence of complications | 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. | During hospital stay (expected average of 7 days) | — |
Countries
France
Outcome results
None listed