NCT07661758 Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section
| NCT ID | NCT07661758 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tanta University |
| Condition | Intravenous Lidocaine |
| Study Type | INTERVENTIONAL |
| Enrollment | 680 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 680 participants in total. It began in 2026-07-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07661758 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Intravenous Lidocaine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07661758 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 680 participants.
Is NCT07661758 currently recruiting?
Yes, NCT07661758 is actively recruiting participants. Contact the research team at osamarehab@med.tanta.edu.eg for enrollment information.
Where is the NCT07661758 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT07661758 clinical trial?
NCT07661758 is sponsored by Tanta University. The trial plans to enroll 680 participants.