Effect of Intrathecal Neostigmine on Post-dural Puncture Headache. (NCT05289323) | Clinical Trial Compass
CompletedPhase 4
Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
Egypt722 participantsStarted 2022-04-25
Plain-language summary
Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has been investigated widely and found to be an effective adjuvant to bupivacaine for postoperative analgesia.
The objective of the current study is to investigate the possible prophylactic role of intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block.
Exclusion Criteria:
* Body mass index more than or equal to 35 kg/m2.
* Any contraindication to Intrathecal blocks such as local infection, bleeding disorders, or parturient refusal.
* Allergy to neostigmine or other drugs will be used in the study.
* Long-term opioid use.
* A history of chronic pain, migraine, cluster headache.
* Digestive problems with nausea and vomiting; cognitive dysfunction or memory disorders.
* Significant renal, hepatic, and cardiovascular diseases.
* History of urinary retention or bronchial asthma.
* Inadequate or failed Intrathecal block.
* Complicated pregnancy such as hypertensive disorders of the pregnancy, abnormal placenta, or uterine atony.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of post-dural puncture headache
Timeframe: Two times daily for five days after intrathecal block.