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Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Primary Purpose

Postdural Puncture Headache

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pyridostigmine
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pyridostigmine

    Placebo

    Arm Description

    Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.

    Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

    Outcomes

    Primary Outcome Measures

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

    The need for an Epidural blood patch in the Pyridostigmine and control groups.
    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.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    July 29, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05969119
    Brief Title
    Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
    Official Title
    Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postdural Puncture Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pyridostigmine
    Arm Type
    Experimental
    Arm Description
    Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Pyridostigmine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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 Outcome Measure Information:
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    15 minutes after sitting upright
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    6 hours
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    12 hours
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    24 hours
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    36 hours
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    48 hours
    Title
    The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
    Description
    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.
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    The need for an Epidural blood patch in the Pyridostigmine and control groups.
    Description
    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.
    Time Frame
    72 hours
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    Before giving the Pyridostigmine or the Placebo
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    6 hours after the intervention
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    12 hours after the intervention
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    24 hours after the intervention
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    36 hours after the intervention
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    48 hours after the intervention
    Title
    Appearance of neck stiffness in the Pyridostigmine and control groups.
    Description
    Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.
    Time Frame
    72 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    Before giving the Pyridostigmine or the Placebo
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    6 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    12 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    24 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    36 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    48 hours after the intervention
    Title
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
    Description
    Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.
    Time Frame
    72 hours after the intervention

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Riham Fa Galal, Lecturer
    Phone
    +201022739211
    Email
    rihamfathygalal@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    1 year after study publication.
    IPD Sharing Access Criteria
    available to all

    Learn more about this trial

    Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

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