The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.
placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France
Hospices Civils de Lyon / hôpital de la Croix rousse
Lyon, France
Rate of blood patch use
Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.
Time frame: Day 15
Side effects
Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
Time frame: Day 15
Duration of headache
Duration of headache in each group (control and experimental) between day 0 and day 15
Time frame: Day 15
Intensity of headache
Intensity of headache in each group (control and experimental) between day 0 and day 15
Time frame: Day 15
analgesic use (type and duration) in each group (control and experimental)
analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
Time frame: Day 15
blood-patch number
blood-patch number per patient in each group (control and experimental) between day 0 and day 15
Time frame: Day 15
Time to first analgesic use after injection of treatment (Synacthène® or placebo)
Time frame: Day 15
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