BACKGROUND:Pain is a common complaint after day surgery, and there is still a controversy surrounding the use of selective cyclooxygenase-2 (COX-2) inhibitors. In the present prospective, randomized, double-blind study we compared pain management with a selective (COX-2) inhibitor (etoricoxib) with pain management using sustained-release tramadolafter elective hallux valgus surgery. METHODS:One hundred ASA 1 to 2 female patients were randomized into 2 groups of 50 patients each; oral etoricoxib 120 mg x 1 x IV + 90 mg x 1 x day V-VII and oral tramadol sustained-release 100 mg x 2 x VII. Pain, pain relief, satisfaction with pain management, and need for rescue medication were evaluated during the first 7 postoperative days. A computed tomography scan evaluating bone healing was performed 12 weeks after surgery. A clinical evaluation of outcome (healing, mobility, and patient-assessed satisfaction) was performed 16 weeks after surgery. RESULTS: Two patients withdrew before discharge from the hospital. Ninety-eight patients, 81 ASA 1 and 17 ASA 2 (82 nonsmokers and 14 smokers), mean age 49 years (19-65), weight 64 (47-83) kg, and height 167 (154-183) cm were evaluated. Overall pain was well managed, but the mean visual analog scale (VAS) was significantly lower among etoricoxib patients evaluated during the entire 7-day period studied (12.5 + or - 8.3 vs. 17.3 + or - 11, P < 0.05). patient's grading of pain relief (92 + or - 12 vs. 85 + or - 15, P < 0.05) and satisfaction with pain medication (47/49 vs. 39/49, P < 0.05) was higher among etoricoxib patients. Patients receiving tramadol reported significantly more side effects. Six patients, all in the tramadol group, discontinued the study because of side effects (P < 0.05). At 14-day follow-up 1 patient in the etoricoxib group and 5 patients in the tramadol group exhibited minor irritation in the wound area. The 12-week computed tomography scan showed good healing in 82 patients, 43 in the etoricoxib group, and 39 in the tramadol group. The study found ongoing healing in 11 patients, 4 in the etoricoxib group and 7 in the tramadol group. The 16-week patient-assessed Health Profile Quality of life revealed high patient satisfaction overall; 47 patients in each study group rated the outcome as satisfactory and the mean change in the patient-assessed quality of lifeVAS score was 6.2 and 2.6 for the etoricoxib and tramadol groups, respectively. Clinical follow-up at 16 weeks showed high functionality and no signs or symptoms of improper healing in any patient. CONCLUSION:Etoricoxib was found to be more effective and associated with fewer side effects in comparison with tramadol sustained release as a component of multimodel analgesia after elective hallux valgus surgery. There were no signs of impaired wound or bone healing associated with the use of etoricoxib.
RCT Entities:
BACKGROUND:Pain is a common complaint after day surgery, and there is still a controversy surrounding the use of selective cyclooxygenase-2 (COX-2) inhibitors. In the present prospective, randomized, double-blind study we compared pain management with a selective (COX-2) inhibitor (etoricoxib) with pain management using sustained-release tramadol after elective hallux valgus surgery. METHODS: One hundred ASA 1 to 2 female patients were randomized into 2 groups of 50 patients each; oral etoricoxib 120 mg x 1 x IV + 90 mg x 1 x day V-VII and oral tramadol sustained-release 100 mg x 2 x VII. Pain, pain relief, satisfaction with pain management, and need for rescue medication were evaluated during the first 7 postoperative days. A computed tomography scan evaluating bone healing was performed 12 weeks after surgery. A clinical evaluation of outcome (healing, mobility, and patient-assessed satisfaction) was performed 16 weeks after surgery. RESULTS: Two patients withdrew before discharge from the hospital. Ninety-eight patients, 81 ASA 1 and 17 ASA 2 (82 nonsmokers and 14 smokers), mean age 49 years (19-65), weight 64 (47-83) kg, and height 167 (154-183) cm were evaluated. Overall pain was well managed, but the mean visual analog scale (VAS) was significantly lower among etoricoxibpatients evaluated during the entire 7-day period studied (12.5 + or - 8.3 vs. 17.3 + or - 11, P < 0.05). patient's grading of pain relief (92 + or - 12 vs. 85 + or - 15, P < 0.05) and satisfaction with pain medication (47/49 vs. 39/49, P < 0.05) was higher among etoricoxibpatients. Patients receiving tramadol reported significantly more side effects. Six patients, all in the tramadol group, discontinued the study because of side effects (P < 0.05). At 14-day follow-up 1 patient in the etoricoxib group and 5 patients in the tramadol group exhibited minor irritation in the wound area. The 12-week computed tomography scan showed good healing in 82 patients, 43 in the etoricoxib group, and 39 in the tramadol group. The study found ongoing healing in 11 patients, 4 in the etoricoxib group and 7 in the tramadol group. The 16-week patient-assessed Health Profile Quality of life revealed high patient satisfaction overall; 47 patients in each study group rated the outcome as satisfactory and the mean change in the patient-assessed quality of life VAS score was 6.2 and 2.6 for the etoricoxib and tramadol groups, respectively. Clinical follow-up at 16 weeks showed high functionality and no signs or symptoms of improper healing in any patient. CONCLUSION:Etoricoxib was found to be more effective and associated with fewer side effects in comparison with tramadol sustained release as a component of multimodel analgesia after elective hallux valgus surgery. There were no signs of impaired wound or bone healing associated with the use of etoricoxib.
Authors: Riika Merivirta; Mikko Pitkänen; Jouko Alanen; Elina Haapoja; Mari Koivisto; Kristiina Kuusniemi Journal: J Pain Res Date: 2015-01-16 Impact factor: 3.133