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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Osama M Rehab, MD
- Telefoonnummer: +201095210806
- E-mail: osamarehab@med.tanta.edu.eg
Studie Locaties
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egypte, 31527
- Werving
- Tanta University Hospitals
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Contact:
- Osama M Rehab, MD
- Telefoonnummer: +201095210806
- E-mail: osamarehab@med.tanta.edu.eg
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
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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.
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Placebo-vergelijker: Control group
IV 10 ml isotonic saline over the same period
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IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of intraoperative headache
Tijdsspanne: Up to the end of surgery.
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The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
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Up to the end of surgery.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Severity of intraoperative headache
Tijdsspanne: Up to the end of surgery.
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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.
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Up to the end of surgery.
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The changes in optic nerve sheath diameter
Tijdsspanne: Up to the end of surgery.
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Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery.
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Up to the end of surgery.
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Incidence of shoulder pain
Tijdsspanne: Up to 24 hours after surgery.
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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.
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Up to 24 hours after surgery.
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Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores
Tijdsspanne: Up to 5 minutes after delivery.
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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.
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Up to 5 minutes after delivery.
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side effects
Tijdsspanne: Intraoperative up to 1 hour after surgery.
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Nausea and vomiting, hypotension and bradycardia will be recorded
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Intraoperative up to 1 hour after surgery.
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Incidence of postoperative headache
Tijdsspanne: Up to 24 hours after surgery.
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The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded.
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Up to 24 hours after surgery.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 36265PR75/5/26
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
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