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 range20 Years – 40 Years

SexFEMALE

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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.

What they're measuring

Incidence of post-dural puncture headache

Timeframe: Two times daily for five days after intrathecal block.

Trial details

NCT IDNCT05289323

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-25