Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section (LID-HEAD)

Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Headache; Intravenous Lidocaine; Fundal Pressure
• Intervention / Treatment: Drug: Lidocaine IV; Other: Saline 0.9%

Detailed Description

This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience.

The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP).

Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels.

The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.

• Study Type: Interventional
• Enrollment (Estimated): 680
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Osama M Rehab, MD; Phone Number: +201095210806; Email: osamarehab@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Tanta University Hospitals
      • Contact: Osama M Rehab, MD; Phone Number: +201095210806; Email: osamarehab@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Lidocaine IV; 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.
Placebo Comparator: Control group; IV 10 ml isotonic saline over the same period	Other: Saline 0.9%; IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of intraoperative headache	The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of headache.	Up to the end of surgery.
The changes in optic nerve sheath diameter	Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery.	Up to the end of surgery.
Incidence of shoulder pain	The incidence of shoulder pain that may occur intraoperatively and up to 24 hours after surgery will be recorded by asking the patients if they have any pain in their shoulder area. The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of shoulder pain.	Up to 24 hours after surgery.
Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores	Neonatal Apgar scores which include five signs (appearance, pulse, grimace, activity, and respiration) will be recorded at 1 min and 5 minutes after delivery. Each sign has a score of 0, 1, 2 with a total score of 10. Scores more than 6 indicate normal good health.	Up to 5 minutes after delivery.
side effects	Nausea and vomiting, hypotension and bradycardia will be recorded	Intraoperative up to 1 hour after surgery.
Incidence of postoperative headache	The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded.	Up to 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 2, 2026

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 36265PR75/5/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author.
• IPD Sharing Time Frame: After completion of the study.
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No