Postdural Puncture HeadachePhase 4NCT05969119
Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
A Phase 4 study testing Pyridostigmine in people with Postdural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Pyridostigmine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2023to 3 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with PDPH and a visual analog scale (VAS) score <5.
- Patients with history of chronic headache, cluster headache, migraine, convulsions.
- Patients with history of cerebrovascular accident, previous neurological diseases.
- Patients with preeclampsia, eclampsia, coagulopathy.
- Patients with severe bleeding (>20% of blood volume).
- Patients undergoing treatment with vasopressors.
- Patients with bronchial asthma.
- Patients with arrhythmia, and any type of heart block.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postdural Puncture Headache
- Being tested
- Pyridostigmine, Placebo
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pyridostigmine | Experimental | Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours. Receives: Drug: Pyridostigmine |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 Jul 2023
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, riham fathy galal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969119
- Sponsor's protocol ID
- SUEZ Med-IRB 1/2023
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: according to the researchers plan
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
- ClinicalTrials.gov ID
- NCT05969119
- Acronym / sponsor ID
- SUEZ Med-IRB 1/2023
- Conditions
- Postdural Puncture Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridostigmine | Experimental | Drug: PyridostigmineParturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours. |
| Placebo | Placebo comparator | Drug: PlaceboParturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with PDPH and a visual analog scale (VAS) score <5.
- Patients with history of chronic headache, cluster headache, migraine, convulsions.
- Patients with history of cerebrovascular accident, previous neurological diseases.
- Patients with preeclampsia, eclampsia, coagulopathy.
- Patients with severe bleeding (>20% of blood volume).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyridostigmineParturients 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. | Drug | Pyridostigmine |
| PlaceboParturients 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. | Drug | Placebo |
Primary outcome
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
Time frame: 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.
15 secondary outcomes
The need for an Epidural blood patch in the Pyridostigmine and control groups.
Time frame: 72 hours
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: Before giving the Pyridostigmine or the Placebo
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 6 hours after the intervention
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 12 hours after the intervention
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 24 hours after the intervention
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 36 hours after the intervention
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 48 hours after the intervention
Appearance of neck stiffness in the Pyridostigmine and control groups.
Time frame: 72 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: Before giving the Pyridostigmine or the Placebo
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 6 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 12 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 24 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 36 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 48 hours after the intervention
Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
Time frame: 72 hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided. according to the researchers plan
Related trials for Postdural Puncture Headache
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pyridostigmine in people with Postdural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group. (time frame: 15 minutes after sitting upright). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.