Results
We initially selected 80 patients, of whom 11 were excluded after their
caesarean section.
Reasons for drop-out were: four patients because of BMI ≥ 35, three
patients because they refused the prescribed medication doses after
caesarean section, two patients because of ketamine administration
during their caesarean section and two patients because of failed spinal
analgesia. At the end, a total of 69 patients were included in the study
and randomly allocated into two groups: 35 patients in the ropivacaine
group, and 34 in the placebo group (Figure 1). Patient’s baseline
characteristics were comparable among the two groups (Table 1).
As primary outcome, the morphine consumption (mean ± standard deviation)
was significantly reduced by 8.05 mg (P value = 0.047) in the
ropivacaine group compared to the placebo group, with respectively 21.52
mg ± 21.56, and 29.57 mg ± 22.38 morphine consumption (Table 2).
For secondary outcomes no significant differences were observed in pain
evaluated by VAS comparing the ropivacaine group to the placebo group,
except for pain at mobilisation 6 hours after caesarean section. Pain by
VAS at mobilisation 6 hours after surgery was 3.90 ± 2.66 in the
ropivacaine group and 5.36 ± 2.55 in the placebo group (P value = 0.03)
(Figure 2).
Pain by VAS at rest 6 hours after surgery (ropivacaine 2.73 ± 1.98 vs.
placebo 3.79 ± 2.43 (P value = 0.08)), at rest 12 hours after surgery
(ropivacaine 3.53 ± 2.19 vs. placebo 3.67 ± 2.46 (P value = 0.07)) and
at mobilisation 48 hours after surgery (ropivacaine 3.14 ± 2.09 vs.
placebo 4.13 ± 2.24 (P value = 0.06)) showed a trend toward significance
in favour of ropivacaine. No significant differences were observed for
the incidence of adverse effects (post-operative nausea/vomiting and
pruritus) (Figure 3). No significant differences were observed for time
of first ambulation (Table 3). No pump failure or infection sites were
observed. No breastfeeding problems were observed during
hospitalisation.