| INTERVENTIONS |
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Intervention type
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Intervention name
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Dose
|
Duration
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Intervention description
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Group size
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Nature of control
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| Control Group |
G3 Standard Spinal Anesthesia with IV Placebo |
IV Saline bolus then infusion
Spinal anesthesia with: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 100 micrograms of Morphine (1 ml), following fluid resuscitation with crystalloids.
|
per-operative time |
After monitoring and placement of a large-caliber peripheral venous line, all parturients in this group receive isotonic saline solution in a syringe administered intravenously (IVD) 15 minutes before spinal anesthesia.
A standard spinal anesthesia will be performed for each patient in this group: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 100 micrograms of Morphine (1 ml) after fluid resuscitation with crystalloids.
A continuous infusion via an electronic syringe pump (ESP) containing isotonic saline solution will be continued until the end of the procedure and then stopped. |
42 |
Placebo |
| Experimental Group |
G2 IV Lidocaine without spinal morphine |
Lidocaine 2% at a dose of 1.5 mg/kg as an IV Bolus then 1.5 mg/kg/h infusion
Spinal anesthesia with: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 1ml of saline, following fluid resuscitation with crystalloids.
|
per-operative time |
The parturients in this group receive Xylocaine 2% intravenously (Xylocaine 20mg/ml without preservatives, injectable solution, Lidocaine Hydrochloride): Each ampoule of Xylocaine 2% contains 10 ml, equivalent to 200 mg, diluted in 20 ml so that each 1 ml corresponds to 10 mg.
After monitoring the parturient and after establishing a large-caliber peripheral venous line, she receives Lidocaine 2% at a dose of 1.5 mg/kg as an intravenous bolus injection 15 minutes before spinal anesthesia.
The patient then undergoes spinal anesthesia with: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 1mL of Saline, following fluid resuscitation with crystalloids.
A maintenance dose of Lidocaine 2% through an electronic syringe pump (ESP) at a rate of 1.5 mg/kg/h will be continued throughout the surgical procedure.
This infusion will be discontinued at the end of the procedure.
|
42 |
|
| Experimental Group |
G1 IV lidocaine with spinal morphine |
Lidocaine 2% at a dose of 1.5 mg/kg as an IV Bolus then 1.5 mg/kg/h infusion
Spinal anesthesia with: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 100 micrograms of Morphine (1 ml), following fluid resuscitation with crystalloids.
|
per-operative time |
The parturients in this group receive Xylocaine 2% intravenously (Xylocaine 20mg/ml without preservatives, injectable solution, Lidocaine Hydrochloride): Each ampoule of Xylocaine 2% contains 10 ml, equivalent to 200 mg, diluted in 20 ml so that each 1 ml corresponds to 10 mg.
After monitoring the parturient and after establishing a large-caliber peripheral venous line, she receives Lidocaine 2% at a dose of 1.5 mg/kg as an intravenous bolus injection 15 minutes before spinal anesthesia.
The patient then undergoes spinal anesthesia with: 10 mg of hyperbaric Bupivacaine at 0.5% (2 ml) + 2.5 micrograms of Sufentanil (0.5 ml) + 100 micrograms of Morphine (1 ml), following fluid resuscitation with crystalloids.
A maintenance dose of Lidocaine 2% through an electronic syringe pump (ESP) at a rate of 1.5 mg/kg/h will be continued throughout the surgical procedure.
This infusion will be discontinued at the end of the procedure.
|
42 |
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