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Completed

NCT Number: NCT05969119

Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent Dural puncture during epidural anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The increased level of acetylcholine would produce cerebral vasoconstriction.

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Key information

Conditions

Postdural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Suez General Hospital

Suez, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients American Society of anesthesiologists' physical status (ASA) II because of pregnancy.
  • Patients diagnosed with Postdural puncture headache following intrathecal spinal anesthesia for elective caesarean delivery.

Exclusion criteria

  • Patients with PDPH and a visual analog scale (VAS) score <5.
  • Patients with history of chronic headache, cluster headache, migraine, convulsions.
  • Patients with history of cerebrovascular accident, previous neurological diseases.
  • Patients with preeclampsia, eclampsia, coagulopathy.
  • Patients with severe bleeding (>20% of blood volume).
  • Patients undergoing treatment with vasopressors.
  • Patients with bronchial asthma.
  • Patients with arrhythmia, and any type of heart block.

Treatment and study plan

Pyridostigmine

Drug

Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours or Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

Placebo

Drug

Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

Primary outcomes

  1. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 15 minutes after sitting upright

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) where 10 refers to the worst pain at 0 hours.

  2. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 6 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 6 hours.

  3. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 12 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 12 hours.

  4. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 24 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 24 hours.

  5. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 36 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 36 hours.

  6. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 48 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 48 hours.

  7. The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Time frame: 72 hours

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 72hours.

Secondary outcomes

  1. The need for an Epidural blood patch in the Pyridostigmine and control groups.

    Time frame: 72 hours

    An EBP will be performed during the study if the VAS(Visual analogue scale) will be ≥5 after 72 hours from intervention start following parturient approval and consent, or if requested by the parturient at any time during the study.

  2. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: Before giving the Pyridostigmine or the Placebo

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  3. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 6 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  4. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 12 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  5. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 24 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  6. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 36 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  7. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 48 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  8. Appearance of neck stiffness in the Pyridostigmine and control groups.

    Time frame: 72 hours after the intervention

    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.

  9. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: Before giving the Pyridostigmine or the Placebo

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  10. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 6 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  11. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 12 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  12. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 24 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  13. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 36 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  14. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 48 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

  15. Appearance of Nausea and vomiting in the Pyridostigmine and control groups.

    Time frame: 72 hours after the intervention

    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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