Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pregabalin (150 Milligrams [mg])	Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
Pregabalin (300 mg)	Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
Placebo	Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.

Participant Flow:   Overall Study

	Pregabalin (150 Milligrams [mg])	Pregabalin (300 mg)	Placebo
STARTED	103	100	104
Received Treatment	98	96	98
COMPLETED	77	63	71
NOT COMPLETED	26	37	33
Adverse Event	11	17	13
Lost to Follow-up	1	2	1
Unknown	4	9	6
Withdrawal by Subject	5	5	7
Randomized But Not Treated	5	4	6

Reporting Groups

	Description
Pregabalin (150 mg)	Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
Pregabalin (300 mg)	Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
Placebo	Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.

Baseline Measures

	Pregabalin (150 mg)	Pregabalin (300 mg)	Placebo	Total
Number of Participants   [units: participants]	98	96	98	292
Age, Customized   [units: participants]
18 to 44 years	1	2	4	7
45 to 64 years	52	44	49	145
> = 65 years	45	50	45	140
Gender   [units: participants]
Female	60	61	54	175
Male	38	35	44	117

1.  Primary:

Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)   [ Time Frame: 48 hours after surgery ]

2.  Secondary:

Cumulative Total Amount of Opioids Used During the Entire Hospital Stay   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours ]

3.  Secondary:

Opioids Used Post Discharge   [ Time Frame: Week 2, Week 4, Week 6/Early Termination (ET) ]

4.  Secondary:

Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)   [ Time Frame: 24 hours, 48 hours, 72 hours ]

5.  Secondary:

Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]   [ Time Frame: Week 2, Week 4, Week 6/ET ]

6.  Secondary:

Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups   [ Time Frame: Week 2, Week 4, Week 6/ET ]

7.  Secondary:

Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group   [ Time Frame: Week 2, Week 4, Week 6/ET ]

8.  Secondary:

Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4   [ Time Frame: Week 4 ]

9.  Secondary:

Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4   [ Time Frame: Week 4 ]

10.  Secondary:

Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET   [ Time Frame: Week 6/ET ]

11.  Secondary:

Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET   [ Time Frame: Week 6/ET ]

12.  Secondary:

The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET ]

13.  Secondary:

The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET ]

14.  Secondary:

The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET ]

15.  Secondary:

The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET ]

16.  Secondary:

Total Clinically Meaningful Event (CME) Score   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET ]

17.  Secondary:

Pain Interference Index Score as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

18.  Secondary:

Pain Interference With Relations With People as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

19.  Secondary:

Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

20.  Secondary:

Pain Interference With General Activity as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

21.  Secondary:

Pain Interference With Mood as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

22.  Secondary:

Pain Interference With Walking Ability as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

23.  Secondary:

Pain Interference With Normal Work as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

24.  Secondary:

Pain Interference With Sleep as Measured by the m-BPI-sf   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 ]

25.  Secondary:

Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)   [ Time Frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET ]

26.  Secondary:

Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS   [ Time Frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET ]

27.  Secondary:

Current Pain During the Hospital Stay Assessed by the Pain NRS   [ Time Frame: 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay ]

28.  Secondary:

Pain-Related Sleep Interference Post Surgery   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET ]

29.  Secondary:

Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery   [ Time Frame: Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery ]

30.  Secondary:

Timed Up-and-Go (TUG)   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET ]

31.  Secondary:

Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET ]

32.  Secondary:

ROM Assessment of the Passive Flexion of the Surgical Knee   [ Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET ]

33.  Secondary:

Time From End of Surgery to Meet Hospital Discharge Criteria   [ Time Frame: time from end of surgery up to 192 hours post surgery ]

34.  Secondary:

Time From End of Surgery to Actual Discharge   [ Time Frame: time from end of surgery up to 192 hours post surgery ]

35.  Secondary:

Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET ]

36.  Secondary:

Satisfaction With Medication Characteristics Measured by the PTSS   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET ]

37.  Secondary:

Satisfaction With Medication Efficacy Measured by the PTSS   [ Time Frame: Discharge, Week 2, Week 4, Week 6/ET ]

38.  Secondary:

Overall Satisfaction Measured by the PTSS   [ Time Frame: Discharge, Week 2, Week 4, and Week 6/ET ]

39.  Secondary:

Overall Pain Relief Measured by the PTSS   [ Time Frame: Discharge, Week 2, Week 4, and Week 6/ET ]

40.  Secondary:

Number of Subjects With Global Evaluation of Study Medication Scores   [ Time Frame: Discharge, Week 2, Week 4, and Week 6/ET ]

41.  Secondary:

Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)   [ Time Frame: Month 3, Month 6 (phone call) ]

42.  Secondary:

Neuropathic Pain Symptom Inventory (NPSI)   [ Time Frame: Month 3, Month 6 (phone call) ]