Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section

Sponsor
Tanta University
Study ID
NCT07661758
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Fundal Pressure
  • Headache
  • Intravenous Lidocaine

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine IV — DRUG
    IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision after ensuring negative baseline headache.
  • Saline 0.9% — OTHER
    IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
680 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Lidocaine group
    IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision
  • Placebo Comparator: Control group
    IV 10 ml isotonic saline over the same period

Primary Outcome Measure

Incidence of intraoperative headache [ Time Frame: Up to the end of surgery. ]

Central Contacts

Related Studies