Table 2 Summary of efficacy endpoints

Primary endpoints

Value (95% CI)

LS Mean Change from Baseline Average Pain Intensity at Rest over Days 1–3 (0–10 point NRS)

-3.39 (-3.74, -3.04)

-3.93 (-4.17, -3.69)

p = 0.018

-3.87 (-4.11, -3.64)

p = 0.009

-3.83 (-4.07, -3.59)

LS Geometric Mean Total Daily Dose of Morphine Over Days 1 to 3 mg

13.4 (11.2, 16.0)

8.87 (7.88, 9.97)

p < 0.001

9.25 (8.26, 10.4)

p < 0.001

8.82 (7.85, 9.91)

Raw Geometric Mean Total Daily Dose Over Days 1 to 3

13.5

8.84

N/A

9.26

N/A

8.83

Other endpoints

LS Mean Change from Baseline Average Pain Intensity at Rest over Days 4–7 (0–10 point NRS)

-4.03 (-4.39, -3.67)

-4.74 (-5.00, -4.49)

p < 0.001

-4.92 (-5.16, -4.67)

p < 0.001

-4.70 (-4.95, -4.45)

Postoperative Morphine Consumption (mg)

3.43 (2.69, 4.36)

1.72 (1.46, 2.02)

N/A

1.70 (1.46, 1.99)

N/A

2.06 (1.76, 2.41)

LS Geometric Mean Total Daily Dose Over Days 4 to 7

Raw Geometric Mean Total Daily Dose Over Days 4 to 7

3.49

1.71

N/A

1.70

N/A

2.06

LS Mean Change from Baseline in Pain Intensity at Knee Flexion over Days 1 to 3 (0- to 10-point NRS)

-1.59 (-2.00, -1.17)

-1.96 (-2.24, -1.68)

p = 0.057

-2.05 (-2.32, -1.78)

p = 0.129

-2.00 (-2.28, -1.72)

LS Mean Change from Baseline in Pain Intensity at Knee Flexion over Days 4 to 7 (0- to 10-point NRS)

-3.61 (-4.05, -3.18)

-4.78 (-5.08, -4.48)

p < 0.001

-5.16 (-5.45, -4.87)

p < 0.001

-4.56 (-4.85, -4.26)