The Effectiveness of Perioperative Parecoxib Intravenous Administration in Foot and Ankle Surgery: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial

CATEGORY: Trauma; Ankle INTRODUCTION/PURPOSE: Parecoxib is indicated for the short-term treatment of postoperative pain in adults. A systematic review assessed the analgesic efficacy of single dose intravenous (IV) or intramuscular (IM) parecoxib in acute postoperative pain and concluded that parecoxib is an effective analgesic in the postoperative setting in adults. However, little is known about its effectiveness in the perioperative intravenous administration in foot and ankle surgery. The present study conducts a double- blinded prospective randomized controlled trial via an 'intention-to-treat analysis' principle to compare the effectiveness of perioperative parecoxib versus placebo in patients with unstable ankle fractures who have surgical indications. METHODS: A total of 40 patients undergoing open reduction and internal fixation of the unstable ankle fractures were randomly allocated either to Group A (parecoxib 40 mg IV 30 min before surgery and then an additional 40 mg every 12 hours for 48 hours after surgery [n=20]) or Group B (placebo (saline) [n=20]). The baseline data were recorded in each patient. The efficacy of pain control was assessed by total morphine used, pain intensity (at rest/ambulation) and pain relief (at rest/ambulation) using the verbal numerical rating score (VNRS) from 0 (no pain) to 10 (worst imaginable pain) and the verbal numerical rating percentage (VNRP) from 0 (no relief) to 100 (best relief) respectively, as well as each patient's subjective rating of the medication. The patients' subjective rating of the medication used the classifications of 'excellent', 'good', 'fair', or 'poor'. When the patients were moved to the post-anesthesia care unit (PACU) after surgery, the study procedure was to record the time as 0. The data were then recorded at 0, 4, 12, 24, and 48 hours after surgery by trained personnel. The overall adverse effects experienced by patients were reported in both groups. All outcomes were recorded by trained personnel who were blind to the patient group allocation. All surgeons, anesthesiologists, and patients involved in the process were also blind to the group allocations. The outcomes including efficacy, patients' subjective ratings of the medication, and overall adverse effects were statistically compared between the two groups. RESULTS: From a total of 40 patients in the study, four patients were excluded by the study criteria. The remaining 36 patients continued in the study. The mean age of patients was 49.3 +/- 18.0 years. No significant difference was found regarding the mean age of patients between the two groups (p-value > 0.05). Male patients appeared more frequently in the saline group than the parecoxib group (p-value = 0.018). For the main outcomes, there were no significant differences between the two groups in terms of the pain intensity, pain relief, patients' subjective ratings of the medication at both preoperative and postoperative periods, total quantity of morphine used, and side effects and acute complications of surgery (p-values > 0.05). CONCLUSION: Based on the results of the present study, the perioperative administration of parecoxib could not significantly improve postoperative pain control as defined by the reduction in opioid requirements, lower pain scores, higher pain relief, and higher patients' subjective ratings of the medication when compared to the placebo. Male predominance was significantly found in the placebo group. This may have influenced the level of pain tolerance between the two groups. This may also affect the results as no significant differences of pain parameters between the two groups in the study. Further study with larger numbers of patients is still necessary to clarify the role of preemptive parecoxib on ankle fracture surgery.