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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 : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Post-dural Puncture Headache Drug: Tetracosactide (Synacthène®) Drug: placebo saline (0.9% NaCl) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Cosyntropin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental arm
Tetracosactide (Synacthène®)
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.

Placebo Comparator: Control arm
placebo saline (0.9% NaCl)
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.



Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Duration of headache [ Time Frame: Day 15 ]
    Duration of headache in each group (control and experimental) between day 0 and day 15

  3. Intensity of headache [ Time Frame: Day 15 ]
    Intensity of headache in each group (control and experimental) between day 0 and day 15

  4. 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

  5. blood-patch number [ Time Frame: Day 15 ]
    blood-patch number per patient in each group (control and experimental) between day 0 and day 15

  6. Time to first analgesic use after injection of treatment (Synacthène® or placebo) [ Time Frame: Day 15 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813655


Contacts
Contact: Nadia STEER, MD + 33 4 26 10 92 55 nadia.steer@chu-lyon.fr
Contact: Isabelle DELFOUR +33 4 26 73 27 25 isabelle.delfour@chu-lyon.fr

Locations
France
Hospices Civils de Lyon / hôpital de la Croix rousse Recruiting
Lyon, France, 69004
Contact: Nadia STEER, MD    + 33 4 26 10 92 55    nadia.steer@chu-lyon.fr   
Contact: Isabelle DELFOUR    +33 4 26 73 27 25    isabelle.delfour@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02813655     History of Changes
Other Study ID Numbers: 69HCL15_0429
2015-003357-17 ( EudraCT Number )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Hospices Civils de Lyon:
tetracosactide
Synacthène®
cosyntropin
post-dural syndrom
post-dural puncture headache

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Cosyntropin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs