Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
- Conditions
- Blood PatchPost-Dural Puncture Headache
- Interventions
- Other: Questionnaires
- Registration Number
- NCT05888324
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this study is to identify possible links between conditions for carrying out a blood patch (BP) to treat accidental post dural puncture acute headache (PDPH) in the early post partum period and occurrence of chronic headaches at 1 and 6 months.
- Detailed Description
It is established that accidental dural puncture promotes the onset of chronic headaches in 25 to 60% of cases but the risk factors for the occurrence of this event are not known.
To identify those risk factors, the investigators will analyze the initial conditions of the accidental breach, the initial manifestations of the PDPH, the methods of carrying out the BP and the patient data.
In this study, the investigators will evaluate (phone questionnaire and score) incidence of chronic headaches at 1 month and 6 months after the realization of a blood patch, incidence of chronic low back pain, impact on daily life, incidence of late recurrences of PDPH, incidence of early and distant complications
In case of failure of effectiveness of the first blood patch, the investigators will search for associated factors: patient data, mode of delivery, initial PDPH, conditions for carrying out the BP.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Age greater than or equal to 18 years old,
- Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward,
- Collection of non-opposition after oral and written information,
- Patient under curatorship or guardianship
- Not speaking/understanding French
- BP performed in another indication
- Benefiting from the AME (state medical aid)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with PDPH after epidural analgesia for labor, requiring BP Questionnaires Patients with PDPH after epidural analgesia for labor, requiring BP
- Primary Outcome Measures
Name Time Method Positional Immediately after BloodPatch procedure Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neurosensory disorders Immediately after BloodPatch procedure Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Time to onset Immediately after BloodPatch procedure Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neck pain Immediately after BloodPatch procedure Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Analog visual scale (AVS) At exit of the hospital, up to 2 weeks Patient data collection - Initial efficacy
Completion time after childbirth Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Paresthesias Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Description of the conditions of the accidental breach Immediately after BloodPatch procedure Data collection of diagnosis of the accidental breach :
* noted with the needle,
* intrathecal passage,
* postpartum positional headaches,
* intrathecal catheterVolume injected Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Height of puncture compared to the initial breach Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Parity Immediately after BloodPatch procedure Patient data collection
Adverse events Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Height Immediately after BloodPatch procedure Patient data collection
Weight Immediately after BloodPatch procedure Patient data collection
Mode of delivery Immediately after BloodPatch procedure Patient data collection
Other examinations if performed 1 month after last BloodPatch procedure Patient data collection
Duration of strict decubitus in the immediate afterglow Immediately after BloodPatch procedure Description of the methods of carrying out the BloodPatch (BP)
Age Immediately after BloodPatch procedure Patient data collection
History of headaches or migraines before pregnancy Immediately after BloodPatch procedure Patient data collection
Initial treatment (before 1st BP) Immediately after BloodPatch procedure Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other
Imaging 1 month after last BloodPatch procedure Patient data collection
Lumbar punction 1 month after last BloodPatch procedure Patient data collection
Complications during the initial postpartum stay Immediately after BloodPatch procedure Patient data collection
- Secondary Outcome Measures
Name Time Method Modified Headache Impact Questionnaire (HIT) Month 6 Impact on daily life - Phone questionnaire - Headaches : "Yes/No" Low back pain, "never/rarely/from time to time/often/all the time"
Number of patients with chronic headaches Month 6 Score - phone questionnaire
Number of patients with chronic low back pain Month 6 Score - phone questionnaire
Number of patients who received complementary treatments Month 6 Score - phone questionnaire
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH) Month 6 Score - phone questionnaire
Number of patients who have been rehospitalized Month 6 Score - phone questionnaire
Number of patients consulted for headaches Month 6 Score - phone questionnaire
Patient data collection Month 6 In case of failure of efficacy of the 1st BP: patient data, mode of delivery, initial Post dural puncture acute headache (PDPH), conditions for carrying out the BP
Trial Locations
- Locations (1)
Port-Royal Maternity ward - Cochin Hopsital - APHP
🇫🇷Paris, Ile De France, France