Table 2.
Effectiveness analysis, reduction of pain after topical treatment, according to VAS
| CLIFE1 (Lidocaine plus diclofenac) | CLIFE2 (Lidocaine) | Difference (95% CI) | p-valuea | |
|---|---|---|---|---|
| Intention-to-treat population | (n = 60) | (n = 60) | ||
| Reduction in pain after topical treatment (VAS) | ||||
| First 3 postoperative days, mean (SD) | 7.47 (13.09) | 4.38 (6.75) | −3.21 (−5.75; −0.68) | 0.008 |
| First 6 postoperative days, mean (SD) | 8.08 (14.50) | 4.26 (6.55) | −3.92 (−6.62; −1.22) | 0.004 |
| Reduction in pain after topical treatment (AUC) | ||||
| First 3 postoperative days, mean (SD) | 45.69 (45.15) | 28.16 (41.51) | −17.53 (−33.20; −1.84) | 0.02 |
| First 6 postoperative days, mean (SD) | 73.10 (74.77) | 40.38 (58.72) | −32.72 (−57.04; −8.40) | 0.006 |
| Per-protocol population | (n = 54) | (n = 54) | ||
| Reduction in pain after topical treatment (VAS) | ||||
| First 3 postoperative days, mean (SD) | 7.71 (13.20) | 4.9 (5.96) | −2.82 (−5.39; −0.24) | 0.03 |
| First 6 postoperative days, mean (SD) | 8.4 (14.73) | 4.76 (5.72) | −3.65 (−6.42; −0.89) | 0.01 |
| Reduction in pain after topical treatment (AUC) | ||||
| First 3 postoperative days, mean (SD) | 47.05 (46.05) | 30.71 (38.12) | −16.34 (−32.47; −0.20) | 0.047 |
| First 6 postoperative days, mean (SD) | 75.80 (76.47) | 43.94 (52.95) | −31.86 (−56.98; −6.72) | 0.01 |
SD standard deviation, AUC area under the curve, VAS visual analog scale
aObtained from Mann–Whitney U test