Datta-S. Camann-W. Bader-A. VanderBurgh-L. Clinical effects and maternal
and fetal plasma concentrations of epidural ropivacaine versus bupivacaine
for cesarean section. Anesthesiology. 1995 Jun. 82(6). P 1346-52.
BACKGROUND: Ropivacaine is a new amide local anesthetic structurally
similar to bupivacaine and mepivacaine. Previous studies showed that ropivacaine
has a similar clinical effect as bupivacaine with regard to sensory anesthesia
and slightly less motor blockade than bupivacaine. Ropivacaine appears to
be less cardiotoxic and arrhythmogenic than bupivacaine. The clinical and
pharmacokinetic effects of 0.5% ropivacaine (5 mg/ml) versus 0.5% bupivacaine
(5 mg/ml) when used epidurally for elective cesarean section were investigated.
METHODS: Using a randomized, double-blind study design, 60 ASA physical
status 1 or 2 term parturients presenting for elective cesarean section received
either 0.5% bupivacaine (150 mg) or 0.5% ropivacaine (150 mg) epidurally
in appropriate fractionated doses over a 10-min period. Onset, duration,
and regression of sensory and motor blockade were noted until complete resolution
was observed. Quality of intraoperative anesthesia and abdominal wall muscle
relaxation were noted. Maternal plasma concentrations of local anesthetic
were determined before anesthetic administration and 5, 10, 20, 30, and 60
min and 2, 3, 6, 8, 12, and 24 h after drug injection in 20 subjects. Umbilical
cord blood was obtained at time of delivery for acid-base values and
determination of the free and total plasma concentration of local anesthetic.
Neonates also were examined for neurobehavioral assessments by Scanlon's
and Neurologic and Adaptive Capacity Scores at 2 and 24 h after delivery.
RESULTS: All patients received satisfactory anesthesia for operation.
The onset, duration, and regression of sensory blockade were similar for
both groups. Onset of degree 1 and 2 motor blockade was faster, and duration
of degree 1 motor block was longer in the group receiving bupivacaine.
Hemodynamic sequelae were similar between groups. All neonates had 5-min
Apgar scores of 7 or greater and normal acid-base values and neurobehavioral
assessments. Pharmacokinetic analysis showed that the Cmax was similar for
both drugs (1.3 +/- 0.09 for ropivacaine and 1.1 +/- 0.09 micrograms/ml for
bupivacaine). The T1/2 of the terminal decline in plasma concentration was
shorter for ropivacaine versus bupivacaine (5.2 +/- 0.60 versus 10.9 +/-
1.08 h, respectively; P < 0.01). The free (i.e., unbound) concentrations
of ropivacaine were approximately twice those of bupivacaine in both maternal
and neonatal blood at the time of delivery. The ratio of umbilical vein to
maternal vein concentration of unbound drug was 0.72 for ropivacaine and
0.69 for bupivacaine.
CONCLUSIONS: Ropivacaine, 0.5%, epidurally provided satisfactory and
similar sensory anesthesia compared to 0.5% bupivacaine for elective cesarean
section. The Cmax was similar for both drugs, although the terminal half-life
of ropivacaine was significantly shorter, and the blood concentrations of
free ropivacaine were significantly greater than that for bupivacaine. These
values were less than concentrations shown to be toxic in animals.