Although nonsteroidal antiinflammatory drugs (
NSAIDs) improve
postoperative pain relief after cesarean delivery, they carry potential side effects (e.g.,
bleeding). Perioperative
cyclooxygenase (COX)-2 inhibitors show similar
analgesic efficacy to nonsteroidal antiinflammatory drugs in many surgical models but have not been studied after cesarean delivery. We designed this randomized double-blind study to determine the
analgesic efficacy and
opioid-sparing effects of
valdecoxib after cesarean delivery. Healthy patients undergoing elective cesarean delivery under
spinal anesthesia were randomized to receive oral
valdecoxib 20 mg or placebo every 12 h for 72 h postoperatively. As a result of
cyclooxygenase-2 inhibitors safety concerns that became apparent during this study, the study was terminated early after evaluating 48 patients. We found no differences in total
analgesic consumption between the
valdecoxib and placebo groups (121 +/- 70 versus 143 +/- 77
morphine mg-equivalents, respectively; P = 0.26).
Pain at rest and during activity were similar between the groups despite adequate post hoc power to have detected a clinically significant difference. There were also no differences in IV
morphine requirements, time to first
analgesic request, patient satisfaction, side effects, breast-feeding success, or functional activity.
Postoperative pain was generally well controlled. Adding
valdecoxib after cesarean delivery under
spinal anesthesia with intrathecal
morphine is not supported at this time.