Trial Outcomes & Findings for Effects of Pregabalin on Pain After Total Knee Arthroplasty (NCT NCT01333956)
NCT ID: NCT01333956
Last Updated: 2016-05-18
Results Overview
Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
120 participants
Primary outcome timeframe
2 weeks postoperatively
Results posted on
2016-05-18
Participant Flow
Participant milestones
| Measure |
Control
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose.
|
50mg Arm
Patients will receive 50mg of pregabalin per dose.
|
100mg Arm
Patients will receive 100mg of pregabalin per dose.
|
150mg Arm
Patients will receive 150mg of pregabalin per dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
26
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Control
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose.
|
50mg Arm
Patients will receive 50mg of pregabalin per dose.
|
100mg Arm
Patients will receive 100mg of pregabalin per dose.
|
150mg Arm
Patients will receive 150mg of pregabalin per dose.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
1
|
|
Overall Study
Unable to complete study procedure
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Effects of Pregabalin on Pain After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Control
n=30 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=30 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=30 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=30 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
120 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
32 kg/m ^ 2
STANDARD_DEVIATION 5 • n=5 Participants
|
32 kg/m ^ 2
STANDARD_DEVIATION 6 • n=7 Participants
|
32 kg/m ^ 2
STANDARD_DEVIATION 6 • n=5 Participants
|
30 kg/m ^ 2
STANDARD_DEVIATION 7 • n=4 Participants
|
31.5 kg/m ^ 2
STANDARD_DEVIATION 2.45 • n=21 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
66.3 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeks postoperativelyPain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Postoperative Pain
POD14 Pain score with flexion
|
4 units on a scale
Standard Deviation 2.3
|
4.8 units on a scale
Standard Deviation 2.1
|
4.5 units on a scale
Standard Deviation 2.4
|
4.0 units on a scale
Standard Deviation 2.1
|
|
Postoperative Pain
POD14 Pain score with ambulation
|
3.6 units on a scale
Standard Deviation 2.0
|
3.8 units on a scale
Standard Deviation 1.6
|
3.5 units on a scale
Standard Deviation 1.8
|
3.1 units on a scale
Standard Deviation 1.9
|
|
Postoperative Pain
POD14 Pain score at rest
|
2.9 units on a scale
Standard Deviation 2.3
|
2.9 units on a scale
Standard Deviation 2.0
|
2.8 units on a scale
Standard Deviation 1.8
|
2.7 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 2 weeks postoperativelyOpioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Opioid-Related Symptom Distress Score
ORSDS POD1
|
.4 units on a scale
Interval 0.2 to 0.7
|
.4 units on a scale
Interval 0.2 to 0.6
|
.5 units on a scale
Interval 0.2 to 0.7
|
.4 units on a scale
Interval 0.2 to 0.8
|
|
Opioid-Related Symptom Distress Score
ORSDS POD14
|
.3 units on a scale
Interval 0.1 to 0.5
|
.3 units on a scale
Interval 0.1 to 0.5
|
.3 units on a scale
Interval 0.1 to 0.5
|
.3 units on a scale
Interval 0.0 to 0.4
|
SECONDARY outcome
Timeframe: 1 day postoperativelySelf-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)
Outcome measures
| Measure |
Control
n=29 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=29 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=29 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Self-assessed Sedation and Confusion
Drowsiness POD1 [ORSDS]
|
34.5 percentage of patients
|
37.9 percentage of patients
|
55.2 percentage of patients
|
58.6 percentage of patients
|
|
Self-assessed Sedation and Confusion
Nausea POD1 [ORSDS]
|
34.5 percentage of patients
|
41.4 percentage of patients
|
44.8 percentage of patients
|
31.0 percentage of patients
|
SECONDARY outcome
Timeframe: 3 monthsNRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS)
Preop NRS Pain Score with Flexion
|
4.9 units on a scale
Interval 3.7 to 6.0
|
5.4 units on a scale
Interval 4.3 to 6.5
|
3.9 units on a scale
Interval 2.8 to 5.1
|
5.7 units on a scale
Interval 4.4 to 7.0
|
|
Numeric Rating Scale (NRS)
POD1 NRS Pain Score with Flexion
|
2.8 units on a scale
Interval 1.8 to 4.0
|
2.9 units on a scale
Interval 2.0 to 4.0
|
2.7 units on a scale
Interval 1.8 to 3.3
|
2.5 units on a scale
Interval 1.2 to 3.3
|
|
Numeric Rating Scale (NRS)
POD3 NRS Pain Score with Flexion
|
3.9 units on a scale
Interval 2.8 to 4.8
|
4.2 units on a scale
Interval 3.5 to 5.2
|
3.6 units on a scale
Interval 2.8 to 4.7
|
4.3 units on a scale
Interval 3.3 to 5.3
|
|
Numeric Rating Scale (NRS)
POD14 NRS Pain Score with Flexion
|
4 units on a scale
Interval 3.4 to 5.0
|
4.9 units on a scale
Interval 4.2 to 5.6
|
4.5 units on a scale
Interval 3.7 to 5.4
|
4.2 units on a scale
Interval 3.2 to 5.0
|
|
Numeric Rating Scale (NRS)
3 months NRS Pain Score with Flexion
|
2 units on a scale
Interval 1.0 to 3.0
|
1.9 units on a scale
Interval 0.9 to 2.7
|
1.7 units on a scale
Interval 0.7 to 1.8
|
1.8 units on a scale
Interval 0.9 to 2.3
|
SECONDARY outcome
Timeframe: 3 monthsNeuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Neuropathic Pain
|
0 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 6.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 3 monthsOpioid Usage (POD1, POD 3, 2 weeks, 3 months)
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Opioid Usage
Preop Total Opioid Use (mg)
|
19 mg
Interval 16.0 to 22.0
|
18 mg
Interval 16.0 to 20.0
|
17 mg
Interval 15.0 to 19.0
|
18 mg
Interval 16.0 to 20.0
|
|
Opioid Usage
POD 1 Total Opioid Use (mg)
|
50 mg
Interval 40.0 to 63.0
|
46 mg
Interval 35.0 to 57.0
|
57 mg
Interval 41.0 to 73.0
|
45 mg
Interval 35.0 to 55.0
|
|
Opioid Usage
POD 2 Total Opioid Use (mg)
|
70 mg
Interval 57.0 to 85.0
|
60 mg
Interval 50.0 to 70.0
|
63 mg
Interval 47.0 to 79.0
|
55 mg
Interval 43.0 to 65.0
|
|
Opioid Usage
POD 3 Total Opioid Use (mg)
|
55 mg
Interval 43.0 to 67.0
|
60 mg
Interval 50.0 to 70.0
|
40 mg
Interval 30.0 to 50.0
|
36 mg
Interval 30.0 to 42.0
|
|
Opioid Usage
POD 14 Total Opioid Use (mg)
|
40 mg
Interval 30.0 to 50.0
|
36 mg
Interval 25.0 to 45.0
|
40 mg
Interval 30.0 to 50.0
|
45 mg
Interval 25.0 to 55.0
|
|
Opioid Usage
3 months Total Opioid Use (mg)
|
0 mg
Interval 0.0 to 2.0
|
3 mg
Interval 0.0 to 5.0
|
0 mg
Interval 0.0 to 1.0
|
4 mg
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 2 weeksSatisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)
Outcome measures
| Measure |
Control
n=28 Participants
Patients will receive 0mg of pregabalin
Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.
|
50mg Arm
n=26 Participants
Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
100mg Arm
n=29 Participants
Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
150mg Arm
n=28 Participants
Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
|
|---|---|---|---|---|
|
Satisfaction
|
9 units on a scale
Interval 8.0 to 10.0
|
8 units on a scale
Interval 7.0 to 10.0
|
8 units on a scale
Interval 5.0 to 9.0
|
8 units on a scale
Interval 6.0 to 9.3
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50mg Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100mg Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150mg Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place