Reachout Orthopedics - Issue 2

to rate their pain score at the end of 2, 4, 6, 12, 24 and 48 h postoperatively in the ward. Pain assessments were done at rest and with movement (after the patient completed a 90° logroll while in bed). The time to first rescue analgesic, total morphine consumption at (24 h and 48 h) and the presence of side effects, such as head- ache, rash, nausea, vomiting, dizziness and drowsiness were recorded. The severity of postoperative nausea and vomiting (PONV) was graded on a four-point ordinal scale (I) not at all, (II) sometimes, (III) often or most of the time, and (IV) all of the time with vom- iting [26]. Ondansetron, a rescue antiemetic, (4 mg) IV was given to all patients with PONV score more than II. Patient satisfaction was measured at 24 h post-operatively using a numerical score of 1-4 (1=poor, 2= fair, 3=good, 4=very good). After the study was completed, randomization and allocation were revealed for data analysis. Sample size estimation was made based on morphine consumption in a retrospective sample of 50 patients who was undergoing spinal surgery in our department. The sample size was calculated using power analysis (α=0.05, β=0.8) to detect 50% difference inmorphine consumption between groups at 48 h post-surgery and was found to require at least 24 patients per group. Thus, we decided to include 30 patients per group to allow for possible drop-out. Statistical Analysis Data were presented as median (with inter- quartile range) or mean± standard deviation. While qualitative data were presented as number (frequency distribution). Data such as ASA grade, sex distribution, Patient’s satisfaction, and Side effects were inferred by Chi-square test and fisher’s exact test. Data such as age, weight, height, mean duration of surgery, time of first rescue analgesic and total morphine requirement were inferred by ANOVA and post hoc Bonferroni test was used for in intergroup comparison. Differences in NRS scores were analyzed using the Kruksal-Wallis test and the Mann– Whitney U-test was used for subsequent pair wise comparisons. The p -value of less than 0.05 was considered significance. Results From November 1, 2015 to March 1, 2017, 131 consecutive patients who met the in- clusion criteria were allocated for the study (Fig. 1). Eleven patients refused to participate. Therefore, 120 patients were randomized and included in the study. Characteristics of pa- tients and surgical procedures for each group (Table 1) showed no significant differences between the groups. The Morphine Requirement The time to first rescue analgesic was signifi- cantly prolonged in (D/E)when compared with group D, group E and group P. There was a significant prolongation when groups E and D were compared with group P respectively with no significant difference between group E and group D (Fig. 2). The morphine requirement at 24 h was statistically different between the four groups. There were significantly increased mor- phine requirements in the P group compared with E, D and D/E groups and significantly increased in E and D groups respectively Table 1: Characteristics of patients and surgical procedures in the four groups. Group Variable Group (P) ( n =30) Group (E) ( n =30) Group (D) ( n =30) Group (D/E) ( n =30) P value Age (years) 46.50±8.74 45.26±7.50 48.36±9.80 47.50±10.14 0.455 Male/Female (n) 15/15 17/13 18/12 16/14 0.471 Weight (kg) 81.23±13.24 82.53±12.90 80.60±13.37 78.83±16.78 0.794 Height (cm) 167.46±8.50 165.53±7.71 165.40±8.21 165.00±9.63 0.478 ASA (n)  I 18 18 17 15 0.36  II 7 6 9 10 0.42  III 5 6 4 5 0.23  Duration of surgery (min) 109.9±10.8 115.7±9.8 113.2±13.7 117.8±9.7 0.65 Data are presented as Mean±SD or number (n) Placebo group (P), Etoricoxib group (E), Duloxetine group (D), Duloxetine/Etoricoxib group (D/E). Data were analyzed using ANOVA test with post hoc test (Bonferroni) and Chi-square test Fig. 1: Flow diagram for participant. Enrollment Allocation Analysis Assessed for eligibility (n=140) Randomized (n=120) Excluded (n=20) • Not meeting inclusion criteria (n=9) • Declined to participate (n=11) • Other reasons (n=0) Allocated to intervention (n=30) • Received allocated Analysed (n=30) • Excluded from analysis (give reasons) (n=0) Analysed (n=30) • Excluded from analysis (give reasons) Analysed (n=30) • Excluded from analysis (give reasons) Analysed (n=30) • Excluded from analysis (give reasons) Allocated to intervention (n=30) • Received allocated Allocated to intervention (n=30) • Received allocated Allocated to intervention (n=30) • Received allocated 14 reachOut Orthopedics