Perioperative blood loss and gastrointestinal tolerability of etoricoxib and diclofenac in total hip arthroplasty (ETO-DIC study): a single-center, prospective double-blinded randomized controlled trial

Abstract

Objective:

Non-selective NSAIDs can cause serious gastrointestinal side-effects. Selective COX-2 blockers are a reasonable alternative for pain treatment. They do not seem to affect platelet function and consequently cause a lower perioperative blood loss than non-selective NSAIDs. This study compared etoricoxib and diclofenac during a perioperative (9 days) period after THA to investigate total blood loss and gastrointestinal tolerability. The hypothesis was that etoricoxib is superior to diclofenac.

Methods:

A total of 100 patients (50 in each group) were included in this trial. Etoricoxib (90 mg) was administered once and diclofenac sodium (75 mg) twice daily for 9 days. Total blood loss during and after primary cementless THA was detected. The rate of adverse events (AEs) and serious adverse events (SAEs) was analyzed to detect gastrointestinal tolerability.

Results:

The mean total blood loss (calculated) was 1548 ± SD 468 ml in the etoricoxib (ETO) group and 1649 (SD 547) ml in the diclofenac (DIC) group. The mean duration of THA was 81 min (SD 29) in the DIC and 75 min (SD 30) in the ETO group. Hence, the mean calculated total blood loss was 101 ml higher in the DIC group. This difference was not statistically significant (p = 0.334). Fifty-six patients (28 in each group) received a cell saver retransfusion, but only one patient (ETO group) needed an additional red blood cell transfusion. The hidden blood loss was 1067 ml (SD 603) in the DIC group and 999 ml (SD 378) in the ETO group. The gastrointestinal tolerability (number of adverse and serious adverse events) was not significantly different between groups.

Conclusion:

There was no statistically significant difference in perioperative blood loss after primary THA under etoricoxib (90 mg) compared to diclofenac (75 mg). Furthermore, no gastrointestinal superiority of etoricoxib could be detected during a short period of 9 days.

Keywords: :

• Diclofenac
• Etoricoxib
• Perioperative blood loss
• Total hip arthroplasty

Transparency

Declaration of funding

This study was funded by MSD Sharp & Dohme, Germany. The sponsor did not contribute to the preparation of this article.

Declaration of financial/other relationships

S.H.W. has disclosed that he has received grants from the Medical Faculty of the University of Regensburg (ReForm A) outside the submitted work. F.W. has disclosed grants from the German Research Society (DFG) outside the submitted work. J.G. has disclosed connections to Springer International. C.S., S.B., V.K., H.R.S. and B.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The excellent help of the following is highly appreciated: Karoline Fischer, Tobias Vaitl MD, Franz-Xaver Köck MD, Eva-Maria Bauser MD, Martin Handel MD, Jochen Wolfsteiner MD, Jens Schaumburger MD, Guido Heers MD, Department of Orthopedic Surgery (Regensburg University Medical Centre, Bad Abbach, Germany).