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Published in: Inflammopharmacology 4/2023

12-06-2023 | Celecoxib | Original Article

Postoperative analgesic efficacy and safety of imrecoxib versus celecoxib in hip osteoarthritis patients undergoing total hip arthroplasty: a multi-center, randomized, controlled, non-inferiority study

Authors: Kai Zhang, Xiaoyan Miao, Liqiang Jiang, Shubei Cui, Zhenwu Liu, Zhiyun Wang

Published in: Inflammopharmacology | Issue 4/2023

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Abstract

Background

Imrecoxib, a novel cyclooxygenase-2 inhibitor, possesses a certain postoperative analgesic effect for several orthopedic surgeries. This multi-center, randomized, controlled, non-inferiority study intended to investigate the postoperative analgesic efficacy and safety profile of imrecoxib (versus celecoxib) in hip osteoarthritis patients undergoing total hip arthroplasty (THA).

Methods

156 hip osteoarthritis patients planned for THA were randomized into imrecoxib (N = 78) and celecoxib (N = 78) groups. Patients were orally administrated with imrecoxib or celecoxib 200 mg at 2 h (h) after THA, 200 mg every 12 h to day (D)3, and 200 mg every 24 h to D7; additionally, each patient received patient-controlled analgesia (PCA) for 2 days.

Results

Resting pain visual analogue scale (VAS) score at 6 h, 12 h, D1, D2, D3, and D7 post THA was not varied between imrecoxib and celecoxib groups (all P > 0.050), neither was moving pain VAS score (all P > 0.050). Importantly, the upper of 95% confidence interval of pain VAS score margin between imrecoxib and celecoxib groups was within the non-inferiority threshold (Δ = 1.0), indicating the fact that non-inferiority was established. The additional and total consumption of PCA was not varied between imrecoxib and celecoxib groups (both P > 0.050). Also, no difference was seen in Harris hip score, European Quality of Life 5-Dimensions (EQ-5D) total and VAS scores at month (M)1, M3 between the two groups (all P > 0.050). Besides, the incidences of all adverse events were not different between imrecoxib and celecoxib groups (all P > 0.050).

Conclusion

Imrecoxib is non-inferior to celecoxib for postoperative analgesia in hip osteoarthritis patients undergoing THA.
Literature
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Metadata
Title
Postoperative analgesic efficacy and safety of imrecoxib versus celecoxib in hip osteoarthritis patients undergoing total hip arthroplasty: a multi-center, randomized, controlled, non-inferiority study
Authors
Kai Zhang
Xiaoyan Miao
Liqiang Jiang
Shubei Cui
Zhenwu Liu
Zhiyun Wang
Publication date
12-06-2023
Publisher
Springer International Publishing
Published in
Inflammopharmacology / Issue 4/2023
Print ISSN: 0925-4692
Electronic ISSN: 1568-5608
DOI
https://doi.org/10.1007/s10787-023-01260-7

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