To compare the
analgesic efficacy and safety of the sole
local anesthetic ropivacaine with the combination of both
local anesthetic ropivacaine and opioidergic
analgesic sufentanil given epidurally on the
labor pain control.After institutional review board approval and patient consent, a total of 500 nulliparas requesting epidural labor
analgesia were enrolled and 481 eventually were randomized into 2 groups: a sole
local anesthetic group (
ropivacaine 0.125%) and a combination of
local anesthetic and opioidergic
analgesic group (0.125% ropivacaine + 0.3 μg/mL
sufentanil). After the test dose, a 10-mL epidural
analgesic solution was given in a single bolus, followed by intermittent bolus injection of 10 to 15 mL of the
solution. The primary outcome was the
analgesic efficacy measured using Numerical Rating Scale (NRS) of
pain. Other maternal and infant variables were evaluated as secondary outcomes.A total of 346 participants completed the study. The median NRS
pain score during the 1st stage of labor was significantly lower in the combination group 2.2 (interquartile range [IQR]: 1.8-2.7) comparing to the sole local
analgesic group 2.4 (IQR: 2.0-2.8) (P < 0.0001). No significant difference was observed in NRS
pain score prior
epidural analgesia and during the 2nd stage of labor. Patients in both groups rated same satisfaction of
analgesia. Patients in the sole local
analgesic group experienced fewer side effects than those in the combination group (37.7% vs 47.2%, P = 0.082). The individual
analgesia-related cost in the sole local
analgesic group was less ($5.7 ± 2.06) than that in the combination group ($9.76 ± 3.54) (P < 0.0001). The incidence of 1-minute Apgar ≤ 7 was lower in the sole local
analgesic group 2 (1.2%) than the combination group 10 (5.5%) (P = 0.038). No difference was found between other secondary outcomes.The sole
local anesthetic ropivacaine produces a comparable labor
analgesic effect as the combination of both
local anesthetic ropivacaine and opioidergic
analgesic sufentanil at different stages of labor (ΔNRS = 0.2) but the former has less side effects, lower cost, and less incidence of lower 1-minute Apgar scoring. These results imply the necessity of a systematic reevaluation of epidural labor
analgesia with sole
local anesthetics against combination regimens of
local anesthetics and other
opioids.