Surgery Anaesthesia
Conditions
Interventions
G3 Standard Spinal Anesthesia with IV Placebo
G2 IV Lidocaine without spinal morphine
G1 IV lidocaine with spinal morphine
Sponsors
Syrine Aguir
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Age = 18 years; • Singleton evolving pregnancy; • Gestational age > 35 weeks; • Scheduled or semi-urgent cesarean section (decision-to-extraction interval >10 minutes); • Cesarean section under spinal anesthesia; • ASA (American Society of Anesthesiologists) Score 1 or 2; • Abiding by a 6-hour fasting period before the procedure; • Providing informed consent to participate in the protocol.
Exclusion criteria
Exclusion criteria: • Aged under 18 years; • General anesthesia for the cesarean section; • Emergency cesarean section; • Presence of placental insertion abnormalities; • Retroplacental hematoma; • Pregnancy-related pathologies (Preeclampsia, gestational diabetes...); • Non-cooperative, non-consenting, or having intellectual disability; • ASA (American Society of Anesthesiologists) Score = 3; • Contraindications for spinal anesthesia; • Conduction disorder; • Use of beta-blockers; • Opioid or psychotropic addiction; • Allergy to Lidocaine; • Porphyria; • Severe medical condition: renal, cardiac, or hepatic insufficiency; • A history of seizures or convulsive neurological disease. • Having had a conversion from spinal anesthesia to general anesthesia; • Failure of spinal anesthesia; • Experiencing a perioperative adverse event (anesthetic or surgical incident requiring resuscitation...); • Onset of signs of intoxication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • The intensity of postoperative pain using the visual analog scale (VAS) measured at rest and during activity. • Perioperative hemodynamic variations: heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP). | — |
Secondary
| Measure | Time frame |
|---|---|
| • The time to the first postoperative analgesic request (in hours): between the administration of spinal anesthesia (T0) and the first analgesic request. • The need for additional postoperative analgesia. • Motor and sensory block duration in the postoperative period. • The occurrence of preoperative and postoperative nausea and vomiting. • The occurrence of preoperative and postoperative itching. • The time of bowel movement and the first postoperative ambulation. • Neonatal effects. • Maternal satisfaction. • The development of postoperative chronic pain. | — |
Countries
Tunisia
Contacts
Public ContactMouna Gara
Attending at Anesthesia and Intensive Care Department at Fattouma Bourguiba B Maternity and Neonatology Center in Monastir.
Outcome results
None listed