Valdecoxib for postoperative pain management after cesarean delivery: a randomized, double-blind, placebo-controlled study.
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.
Carvalho
Brendan
B
Department of Anesthesia, Stanford University School of Medicine, Stanford, California 94305, USA. bcarvalho@stanford.edu
Chu
Larry
L
Fuller
Andrea
A
Cohen
Sheila E
SE
Riley
Edward T
ET
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology*; D002585:Cesarean Section / Q000379:methods*; D016861:Cyclooxygenase Inhibitors / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000494:pharmacology*; D008875:Middle Aged; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D011247:Pregnancy; D013449:Sulfonamides / Q000494:pharmacology*; D000096926:Benzenesulfonamides
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; D010919:Placebos; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides