Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Ain Shams University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postdural Puncture Headache

Interventions

PyridostigmineDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Suez General Hospital

Suez, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 15 minutes after sitting upright

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 72 hours

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.

Time frame: Before giving the Pyridostigmine or the Placebo

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.

Time frame: 6 hours after the intervention

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.

Time frame: 12 hours after the intervention

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.

Time frame: 24 hours after the intervention

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.

Time frame: 36 hours after the intervention

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.

Time frame: 48 hours after the intervention

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.

Time frame: 72 hours after the intervention

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