Efficacy of parecoxib sodium combined with epidural morphine for multi-mode analgesia after gynecologic operation: a randomized, double-blind, placebo-controlled, multicenter, prospective study / 中华麻醉学杂志

ABSTRACT

Objective To evaluate the efficacy of parecoxib sodium combined with epidural morphine for multi-mode analgesia after gynecologic operation in a randomized,double-blind,placebo-controlled,multicenter,prospective study.Methods Two hundred and forty ASA Ⅰ or Ⅱ female patients,aged 18-64 yr,scheduled for elective gynecologic operation under combined spinal-epidural anesthesia,were randomly divided into 2 groupscontrol group (group C) and parecoxib sodium group (group P).Normal saline 2 ml or parecoxib sodium 40 mg was injected intravenously 30 min before the start of operation and was injected again 12,24 and 36 h later.Patient-controlled epidural analgesia with morphine was used for postoperative analgesia in both groups.VAS score was maintained ≤ 3 after operation.When VAS score ＞ 4,tramadol was injected as rescue analgesic.The number of attempts,the number of successfully delivered doses,the amount of morphine used,requirement for the rescue analgesic within 48 h after operation and patient' s satisfaction at 48 h after operation were recorded.Blood samples were taken at 48 h after operation for determination of serum creatinine (Cr),blood urea nitrogen (BUN),alanine aminotransferase (ALT),aspartate transaminase (AST),total bilirubin levels and coagulation function.The abnormality in the parameters was recorded.The adverse effects (nausea,vomiting,pruritus) and recovery of gastrointestinal function were recorded within 48 h after operation.Results Of the 225 patients who completed the study,there was 112 cases in group P and 113 cases in group C.Compared with group C,the number of attempts,the number of successfully delivered doses,amount of morphine used and requirement for the rescue analgesic were significantly decreased,the satisfaction score was increased and the incidence of postoperative vomiting was decreased in group P (P ＜ 0.05 or 0.01).There was no significant difference in the incidence of nausea and pruritus,recovery of gastrointestinal function,and abnormality in the parameters of liver and kidney functions and coagulation function between the two groups (P ＞ 0.05).Conclusion Parecoxib sodium combined with epidural morphine can be safely and effectively used for multi-mode analgesia after gynecologic operation and reduce the requirement for morphine and side effects of morphine.