Obstetric Anesthesia Section Editor: David J. Birnbach Valdecoxib for Postoperative Pain Management After Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Study Brendan Carvalho, MBBCh, FRCA* Larry Chu, MD, MS* Andrea Fuller, MD† Sheila E. Cohen, MB, ChB* Edward T. Riley, MD* 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. (Anesth Analg 2006;103:664 –70) More than one million cesarean deliveries are performed each year in the United States and the number is increasing as a result of changing obstetric management (1). Many cesarean deliveries are per- formed under regional anesthesia, with neuraxial opi- oids and supplemental oral or IV opioids given for postoperative pain relief. However, despite this ap- proach, cesarean deliveries result in moderate-to- severe postoperative pain that is often incompletely relieved by pain management protocols (2). The addition of nonsteroidal antiinflammatory drugs (NSAIDs) to a post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements (3–7). Potential maternal side effects (e.g., antiplatelet and gastrointestinal) and ef- fects on the breast-feeding infant have raised concerns about their use in the post-cesarean delivery setting (8,9). Cyclooxygenase-2 specific inhibitors (COX-2 in- hibitors) have been shown to be effective postopera- tive analgesics, decreasing pain scores and analgesic consumption after general, orthopedic, and dental procedures (10 –13). Studies comparing COX-2 inhibi- tors to NSAIDs have demonstrated similar analgesic efficacy and opioid-sparing after surgery in a non- obstetric setting (14,15). COX-2 inhibitors are thus a potentially attractive alternative for post-cesarean use because of their minimal platelet inhibition compared with NSAIDs (10,16). No previous study has evaluated the analgesic efficacy of COX-2 inhibitors in this setting. The objective of this randomized, double-blind, placebo-controlled study was to determine the post- operative analgesic efficacy of a selective COX-2 in- hibitor, valdecoxib, in women undergoing cesarean delivery under spinal anesthesia. METHODS After IRB approval and informed consent, 48 healthy ASA physical status I–II women undergoing From the *Department of Anesthesia, Stanford University School of Medicine Stanford, California; †Northern Colorado Anesthesia Professional Consultants, Fort Collins, Colorado. This independent research project was funded by Pfizer Inc., the manufacturers of valdecoxib, in addition to internal funding by the Department of Anesthesia, Stanford University School of Medicine. Dr. Chu’s work is supported by a career development award from the National Institute of General Medical Sciences of the National Institutes of Health (5K23GM071400-02). Presented, in part (oral presentation), at the 37th Annual Meet- ing of the Society for Obstetric Anesthesia and Perinatology (SOAP), May 2005, Palm Springs, California. Accepted for publication May 16, 2006. Address correspondence and reprint requests to Brendan Car- valho, MBBCh, FRCA, Department of Anesthesia, H3580 Stanford University School of Medicine, Stanford, CA 94305. Address e-mail to bcarvalho@stanford.edu. Copyright © 2006 International Anesthesia Research Society DOI: 10.1213/01.ane.0000229702.42426.a6 Vol. 103, No. 3, September 2006 664