Does intravenous lidocaine associated with spinal anesthesia reduce post-operative pain after C-Section? The i-Lido-CA Trial

Phase 4

• Conditions: Surgery; Anaesthesia

• Registration Number: PACTR202310783988259
• Lead Sponsor: Syrine Aguir

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-17
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 126

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• The intensity of postoperative pain using the visual analog scale (VAS) measured at rest and during activity.<br>• Perioperative hemodynamic variations: heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP).

Secondary Outcome Measures

Name	Time	Method
• The time to the first postoperative analgesic request (in hours): between the administration of spinal anesthesia (T0) and the first analgesic request.<br>• The need for additional postoperative analgesia.<br>• Motor and sensory block duration in the postoperative period.<br>• The occurrence of preoperative and postoperative nausea and vomiting.<br>• The occurrence of preoperative and postoperative itching.<br>• The time of bowel movement and the first postoperative ambulation.<br>• Neonatal effects.<br>• Maternal satisfaction.<br>• The development of postoperative chronic pain.