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Clinical Trials/NCT02813655
NCT02813655TerminatedPhase 2

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

Hospices Civils de Lyon2 sites in 1 country46 target enrollmentStarted: October 1, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
46
Locations
2
Primary Endpoint
Rate of blood patch use
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control arm

Placebo Comparator

placebo saline (0.9% NaCl)

Intervention: placebo saline (0.9% NaCl) (Drug)

Experimental arm

Experimental

Tetracosactide (Synacthène®)

Intervention: Tetracosactide (Synacthène®) (Drug)

Outcomes

Primary Outcomes

Rate of blood patch use

Time Frame: Day 15

Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.

Secondary Outcomes

  • analgesic use (type and duration) in each group (control and experimental)(Day 15)
  • blood-patch number(Day 15)
  • Time to first analgesic use after injection of treatment (Synacthène® or placebo)(Day 15)
  • Duration of headache(Day 15)
  • Side effects(Day 15)
  • Intensity of headache(Day 15)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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