Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Phase 4

Completed

• Conditions: Postdural Puncture Headache
• Interventions: Drug: Placebo; Drug: Pyridostigmine

• Registration Number: NCT05969119
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study Start: 2023-07-25
• Study First Submitted QC: 2023-07-29
• Study First Posted: 2023-08-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-03
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
Pyridostigmine	Pyridostigmine	Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Suez General Hospital; 🇪🇬 Suez, Egypt