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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyridostigmine | Experimental | Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours. |
|
| Placebo | Placebo Comparator | Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyridostigmine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 36 hours |
| The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez General Hospital | Suez | Egypt |
according to the researchers plan
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 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. |
|
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. |
| 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. | 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 72 hours after the intervention |
| 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. | Before giving the Pyridostigmine or the Placebo |
| 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. | 6 hours after the intervention |
| 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. | 12 hours after the intervention |
| 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. | 24 hours after the intervention |
| 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. | 36 hours after the intervention |
| 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. | 48 hours after the intervention |
| 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. | 72 hours after the intervention |
| D009422 | Nervous System Diseases |