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

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ClinicalTrials.gov Identifier: NCT02813655
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE June 22, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Side effects [ Time Frame: Day 15 ]
    Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
  • Duration of headache [ Time Frame: Day 15 ]
    Duration of headache in each group (control and experimental) between day 0 and day 15
  • Intensity of headache [ Time Frame: Day 15 ]
    Intensity of headache in each group (control and experimental) between day 0 and day 15
  • analgesic use (type and duration) in each group (control and experimental) [ Time Frame: Day 15 ]
    analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
  • blood-patch number [ Time Frame: Day 15 ]
    blood-patch number per patient in each group (control and experimental) between day 0 and day 15
  • Time to first analgesic use after injection of treatment (Synacthène® or placebo) [ Time Frame: Day 15 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Side effects [ Time Frame: Day 15 ]
    Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
  • Duration of headache [ Time Frame: Day 15 ]
    Duration of headache in each group (control and experimental) between day 0 and day 15
  • Intensity of headache [ Time Frame: Day 15 ]
    Intensity of headache in each group (control and experimental) between day 0 and day 15
  • analgesic use (type and duration) in each group (control and experimental) [ Time Frame: Day 15 ]
    analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
  • blood-patch number [ Time Frame: Day 15 ]
    blood-patch number per patient in each group (control and experimental) between day 0 and day 15
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Official Title  ICMJE Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-dural Puncture Headache
Intervention  ICMJE
  • Drug: 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.

  • Drug: 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.

Study Arms  ICMJE
  • Experimental: Experimental arm
    Tetracosactide (Synacthène®)
    Intervention: Drug: Tetracosactide (Synacthène®)
  • Placebo Comparator: Control arm
    placebo saline (0.9% NaCl)
    Intervention: Drug: placebo saline (0.9% NaCl)
Publications * Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2016)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nadia STEER, MD + 33 4 26 10 92 55 nadia.steer@chu-lyon.fr
Contact: Lea GARESSUS +33 4 26 73 27 01 Ext-Lea.GARESSUS@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813655
Other Study ID Numbers  ICMJE 69HCL15_0429
2015-003357-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP