Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension
Various treatments have been used for patient with spontaneous intracranial hypotension, but there is not definite approach. Some patients, fortunately, improve spontaneously. Bed rest and increased fluid intake have been advocate. The effectiveness of the caffeine has been shown in some studies, but durable beneficial effect is doubtful. The efficacy of steroids has not been established. However, although there have been no controlled studies, autologous epidural blood patch (EBP) can be considered the treatment of choice for patients. The success rate of EBP for a post lumbar puncture headache is about 90%, but for SIH, is very less about 50% after the first one and 77% after the second. The amount of blood injected must be sufficient. On the other hand, the leak is usually located on dorsal, above the prolonged rest must be respected. One study, have demonstrated, without randomization, a success rate of 90% with a prolonged Trendelenburg after EBP. We decided to do this study, to confirm a superiority of a 24 hours prolonged Trendelenburg position. It's a monocentric study of parallel randomized open blind groups. Patients will be recruited by investigators in our headache emergency room. If the diagnose of SIH is confirmed (orthostatic headache from more than 5 days and less than 28 days with a normal MRI or with sign of SIH) study will be proposed. After a signed information, the patients will be randomized in 2 groups, the investigator is blind of the randomized arm of patient 1. EBP with 24 hours bed rest 2. EBP with 24 hours Trendelenburg position V1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 : randomization and EBP V4 : first evaluation 30 minutes after standing (headaches, associated symptoms) V5 : phone evaluation (safety) D7 V6 : Evaluation at D15 (headache, associated symptoms, safety) V7 : Evaluation at D30 (headache, associated symptoms, control cerebral MRI, HIT6, safety) V8 : last evaluation D60 (headache, associated symptoms,HIT6 safety) Collection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Trendelenburg position
24 hours bed rest after EBP
Autologous Epidural Blood Patch
Lariboisiere Hospital - Centre Urgences Céphalées (CUC)
Paris, France
Recovery at Day 1 without relapse at Day 15
V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
Time frame: Day 1
Recovery at Day 1 without relapse at Day 15
V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
Time frame: day 15
2d EBP and other EBP
Number of patients requires a treatment with a second BP at any time of study (withdrawal study)
Time frame: day 7, 15, 30 and 60
Associated symptoms
Disappearance of associated symptoms
Time frame: day 1, 15, 30 and 60
Headache
Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60
Time frame: day 1,15, 30 and 60
subdural hematoma surgery
Number of patients requires a surgery for life-threatening acute SDH
Time frame: day 7, 15, 30 and 60
cerebral MRI
results of D30 control MRI, compared to baseline MRI
Time frame: day 30
medullar MRI
results of baseline medullar MRI and the link between leak and patient recovery
Time frame: day 60
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Epidural Blood Patch
Volume of blood and localisation of injection / statistical data related with recovery
Time frame: day 60