Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch, Following an Accidental Dural Puncture During Post Partum Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Positional
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •Patient under curatorship or guardianship
- •Not speaking/understanding French
- •BP performed in another indication
- •Benefiting from the AME (state medical aid)
研究组 & 干预措施
Patients with PDPH after epidural analgesia for labor, requiring BP
Patients with PDPH after epidural analgesia for labor, requiring BP
干预措施: Questionnaires (Other)
结局指标
主要结局
Positional
时间窗: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neurosensory disorders
时间窗: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Time to onset
时间窗: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neck pain
时间窗: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Analog visual scale (AVS)
时间窗: At exit of the hospital, up to 2 weeks
Patient data collection - Initial efficacy
Completion time after childbirth
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Paresthesias
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Description of the conditions of the accidental breach
时间窗: Immediately after BloodPatch procedure
Data collection of diagnosis of the accidental breach : * noted with the needle, * intrathecal passage, * postpartum positional headaches, * intrathecal catheter
Volume injected
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Height of puncture compared to the initial breach
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Parity
时间窗: Immediately after BloodPatch procedure
Patient data collection
Adverse events
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Height
时间窗: Immediately after BloodPatch procedure
Patient data collection
Weight
时间窗: Immediately after BloodPatch procedure
Patient data collection
Mode of delivery
时间窗: Immediately after BloodPatch procedure
Patient data collection
Other examinations if performed
时间窗: 1 month after last BloodPatch procedure
Patient data collection
Duration of strict decubitus in the immediate afterglow
时间窗: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Age
时间窗: Immediately after BloodPatch procedure
Patient data collection
History of headaches or migraines before pregnancy
时间窗: Immediately after BloodPatch procedure
Patient data collection
Initial treatment (before 1st BP)
时间窗: Immediately after BloodPatch procedure
Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other
Imaging
时间窗: 1 month after last BloodPatch procedure
Patient data collection
Lumbar punction
时间窗: 1 month after last BloodPatch procedure
Patient data collection
Complications during the initial postpartum stay
时间窗: Immediately after BloodPatch procedure
Patient data collection
Analog visual scale (AVS)
时间窗: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Analog visual scale (AVS)
时间窗: 1 day after BloodPatch procedure
Patient data collection - Initial efficacy
次要结局
- Modified Headache Impact Questionnaire (HIT)(Month 6)
- Number of patients with chronic headaches(Month 6)
- Number of patients with chronic low back pain(Month 6)
- Number of patients who received complementary treatments(Month 6)
- Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)(Month 6)
- Number of patients who have been rehospitalized(Month 6)
- Number of patients consulted for headaches(Month 6)
- Patient data collection(Month 6)
- Number of patients with chronic headaches(Month 1)
- Number of patients with chronic low back pain(Month 1)
- Modified Headache Impact Questionnaire (HIT)(Month 1)
- Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)(Month 1)
- Number of patients who have been rehospitalized(Month 1)
- Number of patients consulted for headaches(Month 1)
- Number of patients who received complementary treatments(Month 1)
- Patient data collection(Month 1)