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

NCT07661758 | Recruiting Phase 3

• 1 other identifier: 36265PR75/5/26
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Lidocaine; Fundal Pressure; Headache

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative headache

  The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.

  Up to the end of surgery.

Secondary Outcomes (6)

• Severity of intraoperative headache

  Up to the end of surgery.

• The changes in optic nerve sheath diameter

  Up to the end of surgery.

• Incidence of shoulder pain

  Up to 24 hours after surgery.

• Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores

  Up to 5 minutes after delivery.

• side effects

  Intraoperative up to 1 hour after surgery.

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Drug: Lidocaine IV

Control group

PLACEBO COMPARATOR

IV 10 ml isotonic saline over the same period

Other: Saline 0.9%

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.

Lidocaine group

Saline 0.9% OTHER

IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Headache

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Osama M Rehab, MD

CONTACT

+201095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: The data will be available upon reasonable request from the corresponding author.

Locations

EG (1)