NSAIDs are frequently used in day case surgery as part of multimodal pain management to provide adequate pain relief and to reduce the risk of opioid-related side effects.18 Hallux valgus surgery has been suggested as a useful model for testing multiple-day analgesic therapy. It has also been used for studying the effects of opioid analgesics as well as NSAIDS.8,19,20 We found a structured 7-day pain analgesic protocol to be associated with acceptable pain levels and high patient satisfaction after elective hallux valgus surgery. The etoricoxib group had lower maximum pain scores during the entire 7-day period and significantly better analgesic effects on the most painful days (days 2 and 3 after surgery). Etoricoxib was also associated with fewer side effects and thus overall higher patient satisfaction with pain medication. In our view, the most important observation is that we found no differences in the healing process. Both the clinical assessment and the CT scan at 12 weeks demonstrated equivalent healing of the wound and the bone in both groups.
We could not verify our primary outcome variable, a difference in need for rescue medication. However, pain VAS scores were lower and satisfaction with pain medication was higher in the etoricoxib group. Toivonen et al. compared the effects of a single 120- mg dose of etoricoxib given 1 hour before placebo control in patients undergoing arthroscopic acromioplasty performed under regional anesthesia. They found beneficial effects on pain and a reduced need for rescue analgesia during the entire 7-day study period from a single dose.21 Sun et al. studied the effects of celecoxib 200 mg twice daily for 3 days after plastic surgery, and found less need for opioid analgesics than for placebo during the 3-day study.22 We did not include a placebo, but an active control, tramadol slow release twice daily. Tramadol is a well-known centrally acting analgesic with an analgesic potency of about 10% of morphine but with less effect on ventilation.23,24 Tramadol has been shown to be effective for the treatment of orthopedic postoperative pain.25 We chose tramadol sustained release in a fixed dose of 100 mg twice daily as a comparison. While this may have been a low dose, resulting in less analgesia when compared with the etoricoxib dose, it was associated with a higher incidence of side effects. We could increase the analgesic effect by giving the subjects a larger dose of tramadol, but would have seen increased complications.
We did not see any clinical or radiological signs of impaired healing, but our findings should be put into perspective. Evaluation of the bone-healing process is not easy. Modeling of the CT image may improve the accuracy of evaluation,26 which is why we used multiplanar reformatted CT images to improve evaluation of nonunion of fractures. However, our study cannot absolutely exclude an increase of clinical pseudoarthrosis from impaired wound healing.
There is a growing body of evidence suggesting that the effects of NSAIDs on bone repair are of limited clinical importance. In a recent animal study no impairment in wound healing was observed from the administration of ketorolac.27 The effect of nonselective NSAIDs on bone healing was also analyzed in a retrospective study in children who had major spine surgery. No signs of impaired bone healing were seen in this retrospective analysis.28 A 2-year follow-up study of patients who received celecoxib postoperatively for 14 days after total knee replacement found no signs of increased risk of loosening of the prosthesis, and concluded that celecoxib may be used safely in conjunction with total knee replacement.29 Because we studied ASA 1 to 2 patients only, and the dose of etoricoxib was reduced for the last 3 days, our findings might not apply to patients given larger doses, patients given doses for a longer period of time, or patients who have other risk factors for poor healing such as smoking, corticosteroids use, diabetes, or delayed healing or nonunion of a fracture.12
We used the EQ-5D to assess patients' evaluation of and satisfaction with outcome, an accepted tool for evaluation of outcomes in health care.20 There were no differences between the groups at 16 weeks.
Our findings are limited to healthy, ASA 1 to 2 patients. The cardiovascular and thrombotic risks associated with NSAIDs will be higher in a less healthy population.30,31 We studied only female patients, who are more prone to postoperative pain, nausea, and vomiting.32,33 We studied a peripheral orthopedic procedure, not a major procedure such as a joint replacement or spine surgery. Additionally, all patients were provided a multimodal analgesia, including the use of local anesthesia infiltration before incision, IV betamethasone, oral paracetamol upon arrival in the step-down unit, and perioperative opioids. Lastly, we used an active control rather than a placebo control. This was done for both ethical reasons, and because tramadol is well established as an effective analgesic.
We conclude that etoricoxib 120 mg oral once daily for 4 days followed by 90 mg oral once daily for 3 days provides better analgesia than does tramadol sustained-release 100 mg twice daily for 7 days. We also conclude that in ASA 1 to 2 patients this regimen of postoperative etoricoxib is not associated with deleterious effects on the healing process.
We would like to thank Aleris Diagnostics and Dr. Tengvar for support with CT imaging and evaluation of CT scans.
a See http://www.aaeditor.org/HWP/Retraction.Notice.pdf.
b See http://www.euroqol.org/.
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