Vitamin IV lidocaine before fundal pressure to prevent headache after cesarean using spinal anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized phase 3 trial compares a single IV lidocaine dose to saline given just before the fundal pressure maneuver in cesarean deliveries performed under spinal anesthesia. The goal is to see if lidocaine can blunt mechanisms that may raise intracranial pressure and trigger headaches after fundal pressure. Eligible adults undergoing elective cesarean section with ASA II are randomized to receive lidocaine or placebo. Outcomes focus on incidence and severity of intraoperative headaches, with safety monitoring for lidocaine-related adverse events. The study builds on observational signals that fundal pressure can provoke headache and explores a pharmacologic strategy to improve maternal experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥ 18 years
* American Society of Anesthesiologists (ASA) Physical Status II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients declined to participate in the trial,
* Patients with history of any type of headache, mental illness, or cerebrovascular diseases
* Previous epidural insertion for painless labor or any other indications;
* Patients on opioid or analgesic medications;
* Those with pregnancy-induced hypertension or diabetic patients,
* Allergy to lidocaine;
* Contraindication or failure of spinal anesthesia.

Where it's running

• Tanta University Hospitals
  Tanta, Gharbia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Osama M Rehab, MD
• Email: osamarehab@med.tanta.edu.eg
• Phone: +201095210806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.