A Phase 3 interventional study of Lidocaine IV and Saline 0.9% in Intravenous Lidocaine, Fundal Pressure and Headache, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Tanta University · Phase 3, Interventional, and Prevention
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.
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 680 is above the median of 65 across 560 interventional studies indexed under Headache.
Browse Headache studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 10 ml isotonic saline over the same period
Other: Saline 0.9%
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.
IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
Incidence of intraoperative headache
The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
Time frame: Up to the end of surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 minutes after delivery.
side effects
Nausea and vomiting, hypotension and bradycardia will be recorded
Time frame: 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.
Time frame: Up to 24 hours after surgery.
Plan to share: Yes — The data will be available upon reasonable request from the corresponding author.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After completion of the study.
Access criteria: The data will be available upon reasonable request from the corresponding author.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.
Of 30 phase 3 interventional studies under Headache, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 4 months is below that.
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Studies of the drug tested here: Lidocaine