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

1. juli 2026 oppdatert av: Osama Rehab, Tanta University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

680

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Rekruttering
        • Tanta University Hospitals
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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 komparator: Control group
IV 10 ml isotonic saline over the same period
Annen: Saline 0.9%
IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of intraoperative headache
Tidsramme: 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.
Up to the end of surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Severity of intraoperative headache
Tidsramme: Up to the end of surgery.
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
Tidsramme: Up to the end of surgery.
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
Tidsramme: Up to 24 hours after surgery.
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
Tidsramme: Up to 5 minutes after delivery.
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
Tidsramme: Intraoperative up to 1 hour after surgery.
Nausea and vomiting, hypotension and bradycardia will be recorded
Intraoperative up to 1 hour after surgery.
Incidence of postoperative headache
Tidsramme: Up to 24 hours after surgery.
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tanta University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

2. november 2026

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 36265PR75/5/26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon reasonable request from the corresponding author.

IPD-delingstidsramme

After completion of the study.

Tilgangskriterier for IPD-deling

The data will be available upon reasonable request from the corresponding author.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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