Postdural Puncture Headache
Conditions
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.
Interventions
DRUGPyridostigmine
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.
DRUGPlacebo
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. |
Countries
Egypt
Outcome results
None listed