Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

• Sponsor: Ain Shams University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05969119
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postdural Puncture Headache	Drug: Pyridostigmine; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyridostigmine Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.	Drug: Pyridostigmine; 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 Comparator: Placebo Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.	Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. Patients with PDPH and a visual analog scale (VAS) score <5.

2. Patients with history of chronic headache, cluster headache, migraine, convulsions.

3. Patients with history of cerebrovascular accident, previous neurological diseases.

4. Patients with preeclampsia, eclampsia, coagulopathy.

5. Patients with severe bleeding (>20% of blood volume).

6. Patients undergoing treatment with vasopressors.

7. Patients with bronchial asthma.

8. Patients with arrhythmia, and any type of heart block.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: riham fathy galal, Lecturer of Anesthesia intensive care and pain management, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05969119
• Other Study ID Numbers: SUEZ Med-IRB 1/2023
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Post-Dural Puncture Headache; Headache; Pyridostigmine Bromide

Study Results

No Results Posted as of Aug 1, 2023