Post-cesarean pain management is essential for early mobilization of the mother so that she
becomes able to care of her newborn. There choices for postoperative analgesia include
spinal, systemic, or both opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local
anesthetic infiltrations of the wound, or transverse abdominis plane blocks, which are
determined by drug availability, regional and individual preferences, resource limitations
and financial considerations. The use of opioids is associated with adverse effects such as
nausea, pruritus, sedation, and occasionally respiratory depression.
Pregabalin is an anticonvulsant drug structurally related to the inhibitory neurotransmitter
gamma amino butyric acid, that exerts its action by binding to the α-2-δ subunit of the
voltage-dependent calcium channel. It reduces the release of the excitatory neurotransmitters
and inhibits the hyperalgesia and central sensitization.
A recent meta-analysis demonstrated that pregabalin reduce the postoperative 24 hours
cumulative opioid consumption and opioid-related adverse effects namely, vomiting and visual
disturbances after surgery. Compared with the use of pregabalin doses lower than 300 mg, the
use of doses higher than 300 mg even reduced opioid consumption by 35%.
It is not known if pregabalin is excreted in human milk. There is a case report on the
extensive excretion of pregabalin in breast milk, but with low measured concentrations in
infant as a consequence of maternal exposure during breast feeding. Food and Drug
Administration recommends to discontinue nursing or to discontinue pregabalin in nursing
mothers. Pre-delivery single exposure to pregabalin is expected to be safe for the newborns.
Up to the authors' best knowledge, this is the first clinical study on the efficacy and
safety of the administration of pregabalin before cesarean delivery.
We hypothesis that the preoperative administration of a single dose of pregabalin will
improve the quality of postoperative analgesia after cesarean delivery.
This placebo-controlled study aims to compare the effects of preoperative administrations of
single oral doses of pregabalin 150 mg and 300 mg on the postoperative pain scores,
cumulative patient controlled morphine consumptions, neonatal Apgar and neurologic and
adaptive capacity scores (NACS), and maternal and neonatal adverse effects in parturients
scheduled to elective Cesarean delivery under spinal anesthesia.