Clinical trial

Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

Name

69HCL15_0429

Description

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.

Trial arms

Trial start

2016-10-01

Estimated PCD

2022-11-01

Trial end

2022-11-21

Status

Terminated

Phase

Early phase I

Treatment

Tetracosactide (Synacthène®)

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.

Arms:

Experimental arm

placebo saline (0.9% NaCl)

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.

Arms:

Control arm

Size

Primary endpoint

Rate of blood patch use

Day 15

Eligibility criteria

Inclusion Criteria: All women who received epidural, spinal, or combined spinal-epidural labour analgesia and presenting post-dural puncture headache: * Intense: with ≥3 / 10 numerical rating pain scale * Appearing within 5 days after delivery * Aggravating in sitting or standing position and / or improving supine * Can be associated with one of the following criteria: tinnitus, nausea, photophobia, neck stiffness or pain, hearing loss * After exclusion of clinically differential diagnoses (preeclampsia or eclampsia, cerebral venous thrombosis, migraine) * Age greater than or equal to 18 years * Affiliation to social security scheme * Inform Consent signed after oral and written information Exclusion Criteria: * Presence of diplopia (indication of immediate blood patch) * Contraindication to ACTH or Synacthène® (unbalanced hypertension, uncontrolled diabetes, uncontrolled psychosis, infectious viral disease state or evolving) * Processing of Torsade de Pointe provider (astenizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine) * Live vaccine in the months prior to inclusion * Hypersensitivity to Synacthène® * Patient who have previously received Synacthène® after delivery * Contraindication to blood patch (fever or leukocytosis, HIV or HCV patient) * Eclampsia or preeclampsia during this pregnancy * Patient who have received prophylactic blood patch (at diagnosis of Accidental Dural Puncture) * Minor under 18 or protected * Psychological disorders do not allowing informed consent * Refusal of participation in the study or participation in another ongoing interventional study * Withdrawal of consent

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

2 products

1 indication

Organization

Hospices Civils de Lyon

Product

Tetracosactide

Indication

Post-dural Puncture Headache

Product

Placebo Saline