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

Post-dural Puncture Headache Clinical Trial

— ESYBRECHE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02813655
• Other study ID #: 69HCL15_0429
• Secondary ID: 2015-003357-17
• Status: Terminated
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: November 21, 2022

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 21, 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-dural Puncture Headache
• Wounds and Injuries

Intervention

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 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Femme Mère Enfant	Bron
France	Hospices Civils de Lyon / hôpital de la Croix rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 15
Secondary	Side effects	Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15	Day 15
Secondary	Duration of headache	Duration of headache in each group (control and experimental) between day 0 and day 15	Day 15
Secondary	Intensity of headache	Intensity of headache in each group (control and experimental) between day 0 and day 15	Day 15
Secondary	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	Day 15
Secondary	blood-patch number	blood-patch number per patient in each group (control and experimental) between day 0 and day 15	Day 15
Secondary	Time to first analgesic use after injection of treatment (Synacthène® or placebo)		Day 15