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

Primary Purpose

Post-dural Puncture Headache

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tetracosactide (Synacthène®)
placebo saline (0.9% NaCl)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-dural Puncture Headache focused on measuring tetracosactide, Synacthène®, cosyntropin, post-dural syndrom, post-dural puncture headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon - Hôpital Femme Mère EnfantRecruiting
  • Hospices Civils de Lyon / hôpital de la Croix rousseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental arm

Control arm

Arm Description

Tetracosactide (Synacthène®)

placebo saline (0.9% NaCl)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Side effects
Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
Duration of headache
Duration of headache in each group (control and experimental) between day 0 and day 15
Intensity of headache
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)
analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
blood-patch number
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)

Full Information

First Posted
June 22, 2016
Last Updated
October 28, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02813655
Brief Title
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Acronym
ESYBRECHE
Official Title
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-dural Puncture Headache
Keywords
tetracosactide, Synacthène®, cosyntropin, post-dural syndrom, post-dural puncture headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Tetracosactide (Synacthène®)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
placebo saline (0.9% NaCl)
Intervention Type
Drug
Intervention Name(s)
Tetracosactide (Synacthène®)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo saline (0.9% NaCl)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of blood patch use
Description
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
Secondary Outcome Measure Information:
Title
Side effects
Description
Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
Time Frame
Day 15
Title
Duration of headache
Description
Duration of headache in each group (control and experimental) between day 0 and day 15
Time Frame
Day 15
Title
Intensity of headache
Description
Intensity of headache in each group (control and experimental) between day 0 and day 15
Time Frame
Day 15
Title
analgesic use (type and duration) in each group (control and experimental)
Description
analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
Time Frame
Day 15
Title
blood-patch number
Description
blood-patch number per patient in each group (control and experimental) between day 0 and day 15
Time Frame
Day 15
Title
Time to first analgesic use after injection of treatment (Synacthène® or placebo)
Time Frame
Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikhail DZIADZKO, MD
Phone
+ 33 4 26 10 92 55
Email
mikhail.dziadzko@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny JOUBERT
Phone
+33 4 26 73 27 27
Email
Fanny.joubert@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
City
Bron
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Chassard
Email
dominique.chassard@chu-lyon.fr
Facility Name
Hospices Civils de Lyon / hôpital de la Croix rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail DZIADZKO, MD
Phone
+ 33 4 26 10 92 55
Email
mikhail.dziadzko@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Fanny JOUBERT
Phone
+33 4 26 73 27 27
Email
fanny.joubert@chu-lyon.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
31915040
Citation
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.
Results Reference
derived

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

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