Effect of Parecoxib as an Adjunct to Patient-Controlled Epidural Analgesia after Abdominal Hysterectomy: A Multicenter, Randomized, Placebo-Controlled Trial

Wei-Feng Liu, Hai-Hua Shu, Guo-Dong Zhao, Shu-Ling Peng, Jin-Fang Xiao, Guan-Rong Zhang, Ke-Xuan Liu, Wen-Qi Huang, Wei-Feng Liu, Hai-Hua Shu, Guo-Dong Zhao, Shu-Ling Peng, Jin-Fang Xiao, Guan-Rong Zhang, Ke-Xuan Liu, Wen-Qi Huang

Abstract

Objective: This multicenter, randomized, placebo-controlled study evaluated the efficacy and side effects of parecoxib during patient-controlled epidural analgesia (PCEA) after abdominal hysterectomy.

Methods: A total of 240 patients who were scheduled for elective abdominal hysterectomy under combined spinal-epidural anesthesia received PCEA plus postoperative intravenous parecoxib 40 mg or saline every 12 h for 48 h after an initial preoperative dose of parecoxib 40 mg or saline. An epidural loading dose of a mixture of 6 mL of 0.25% ropivacaine and 2 mg morphine was administered 30 min before the end of surgery, and PCEA was initiated using 1.25 mg/mL ropivacaine and 0.05 mg/mL morphine with a 2-mL/h background infusion and 2-mL bolus with a 15-min lockout. The primary end point of this study was the quantification of the PCEA-sparing effect of parecoxib.

Results: Demographic data were similar between the two groups. Patients in the parecoxib group received significantly fewer self-administrated boluses (0 (0, 3) vs. 7 (2, 15), P < 0.001) and less epidural morphine (5.01 ± 0.44 vs. 5.95 ± 1.29 mg, P < 0.001) but experienced greater pain relief compared with the control group (P < 0.001). Patient global satisfaction was higher in the parecoxib group than the control group (P < 0.001). Length of hospitalization (9.50 ± 2.1, 95% CI 9.12~9.88 vs. 10.41 ± 2.6, 95% CI 9.95~10.87, P = 0.003) and postoperative vomiting (17% vs. 29%, P < 0.05) were also reduced in the parecoxib group. There were no serious adverse effects in either group.

Conclusion: Our data suggest that adjunctive parecoxib during PCEA following abdominal hysterectomy is safe and efficacious in reducing pain, requirements of epidural analgesics, and side effects.

Trial registration: ClinicalTrials.gov (NCT01566669).

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Distribution of patients randomized to…
Fig 1. Distribution of patients randomized to receive IV parecoxib or placebo for the management of postoperative pain.
PCA = patient-controlled analgesia. ITT = intent-to-treat; EE = efficacy evaluable.
Fig 2. Postoperative numerical rating scores for…
Fig 2. Postoperative numerical rating scores for pain assessments at rest (A) and during coughing (B) at different times after surgery.
Patients scored pain using a NRS (0–100 mm, with 0 representing no pain and 100 mm representing the worst imaginable pain). Values are presented as means and 95% confidence interval. Lines extending above and below each plot represent the 95% confidence interval.

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