Intravenous LidocainePhase 3LID-HEADNCT07661758
Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section
A Phase 3 study testing Lidocaine IV and Saline 0.9% in people with Intravenous Lidocaine and Fundal Pressure, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intravenous Lidocaine, Fundal Pressure, Headache
- What is being tested?
- Lidocaine IV and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 680 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 2 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status II
- Scheduled for elective cesarean section under spinal anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, +201095210806, osamarehab@med.tanta.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Intravenous Lidocaine, Fundal Pressure, Headache
- Being tested
- Lidocaine IV, Saline 0.9%
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lidocaine IV |
| Control group | Placebo comparator | IV 10 ml isotonic saline over the same period Receives: Other: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative headache
The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
Measured: Up to the end of surgery.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 minutes after delivery.
side effects
Nausea and vomiting, hypotension and bradycardia will be recorded
Measured: 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.
Measured: Up to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous LidocaineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661758
- Sponsor's protocol ID
- 36265PR75/5/26
- Acronym
- LID-HEAD
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07661758
- Acronym / sponsor ID
- LID-HEAD / 36265PR75/5/26
- Conditions
- Intravenous Lidocaine, Fundal Pressure, Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine IVIV 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 |
| Control group | Placebo comparator | Other: Saline 0.9%IV 10 ml isotonic saline over the same period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status II
- Scheduled for elective cesarean section under spinal anesthesia
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine IVIV 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. | Drug | Lidocaine group |
| Saline 0.9%IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache. | Other | Control group |
Primary outcome
Incidence of intraoperative headache
Time frame: Up to the end of surgery.
The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
6 secondary outcomes
Severity of intraoperative headache
Time frame: Up to the end of surgery.
The changes in optic nerve sheath diameter
Time frame: Up to the end of surgery.
Incidence of shoulder pain
Time frame: Up to 24 hours after surgery.
Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores
Time frame: Up to 5 minutes after delivery.
side effects
Time frame: Intraoperative up to 1 hour after surgery.
Incidence of postoperative headache
Time frame: Up to 24 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
Intravenous Lidocaine, Laparoscopic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine IV and Saline 0.9% in people with Intravenous Lidocaine and Fundal Pressure, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (+201095210806, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative headache (time frame: Up to the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.