Efficacy of intravenous flurbiprofen axetil with epidural analgesia for post-cesarean section analgesia: a multi-center, prospective, randomized, blinded trial

BackgroundEpidural analgesia provided satisfactory analgesic effects of incision pain after cesarean section. However, uterine contraction pain is also a common complication that cannot be relieved despite adequate levels of sensory blockade by epidural analgesia. This study evaluates the effect of flurbiprofen axetil with patient-controlled epidural analgesia on incision pain and uterine contraction pain after cesarean section.MethodsA multi-center, prospective, randomized, blinded trial was performed. 1000 obstetric patients scheduled for cesarean delivery were randomized to receive epidural analgesia with intravenous flurbiprofen axetil (group EF) or placebo (group E) postoperatively. The primary outcomes were incision pain and uterine contraction pain score 48 hours after a cesarean section. Secondary outcomes were the PCEA attempts, the incidence of complication, satisfaction scores, and return of gastrointestinal (GI) function.ResultsBaseline characteristics were similar between groups. The VAS of uterine contraction pain was significantly lower in group EF than in group E from 12 hours to 48 hours after cesarean delivery (P < 0.01). The VAS of incision pain at rest and on movement was lower in group EF than in group E from 12 hours to 48 hours after cesarean delivery. While sitting or walking, the VAS of incision pain was lower in group EF compared with that in group E. GI function recovered faster in group EF than that in group E (15 ± 6 vs. 25 ± 12, 95%CI 5.7 to 8.7, P < 0.01). The satisfaction scores are higher in group EF than that in group E (3.2 ± 0.5 vs. 2.9 ± 0.5, 95%CI -0.36 to -0.11, P < 0.01).ConclusionCombination flurbiprofen axetil with PCEA provides more effective analgesia for uterine contraction pain and incision pain after cesarean section, with a higher quality of recovery and better satisfaction scores.Trials RegistrationThis study was approved by the Institutional Review Board of Guangzhou Women and Children’s Medical Center (IRB2017062201) and written informed consent was obtained from his or her parents or legal guardians for each pediatric patient in the trial. The trial was registered before patient enrollment at chictr.org.cn (ChiCTR-IOR-17011956, Principal investigator: Ying-Jun She, Date of registration: 2017.07.12). Written informed consent was obtained from patients in the study.