Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section
Recruiting
Phase 3
Interventional Study
Intravenous Lidocaine
Fundal Pressure
Headache
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 680 (estimated)
- Sponsor
- Tanta University · Other
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About This Trial
This prospective randomized controlled multicenter study will be conducted to evaluate the effects of pre-emptive IV lidocaine dose on the incidence and severity of intraoperative headache that may occur after the extra-abdominal manual uterine fundal pressure in patients undergoing cesarean section under spinal anesthesia.
Trial Locations
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Eligibility Criteria
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 ill…
Contacts