Trial Outcomes & Findings for Pain Control With Total Knee Replacement (NCT NCT01680549)
NCT ID: NCT01680549
Last Updated: 2024-01-31
Results Overview
Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
3 days
Results posted on
2024-01-31
Participant Flow
Participant milestones
| Measure |
Gabapentin
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
|
Placebo
Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Control With Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Gabapentin
n=20 Participants
Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
|
Placebo
n=17 Participants
Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPatient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2. Scale range: 0-100 Higher Values = More Pain
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo- Comparator
|
Gabapentin
n=20 Participants
Active pain medicine
|
|---|---|---|
|
Patient Pain Scores
Day 1
|
34.9 units on a scale- VAS
Standard Deviation 26.6
|
46.3 units on a scale- VAS
Standard Deviation 30.5
|
|
Patient Pain Scores
Day 2
|
38.0 units on a scale- VAS
Standard Deviation 15.9
|
39.6 units on a scale- VAS
Standard Deviation 18.8
|
|
Patient Pain Scores
Day 0
|
33.6 units on a scale- VAS
Standard Deviation 23.3
|
40.0 units on a scale- VAS
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: 3 daysNarcotics consumption was recorded on postoperative days 0, 1, and 2.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo- Comparator
|
Gabapentin
n=17 Participants
Active pain medicine
|
|---|---|---|
|
Narcotics Consumption
Day 0
|
4.16 Morphine dose equivalents
Standard Deviation 9.02
|
7.40 Morphine dose equivalents
Standard Deviation 9.10
|
|
Narcotics Consumption
Day 1
|
11.53 Morphine dose equivalents
Standard Deviation 13.90
|
25.02 Morphine dose equivalents
Standard Deviation 17.28
|
|
Narcotics Consumption
Day 2
|
11.61 Morphine dose equivalents
Standard Deviation 10.78
|
21.62 Morphine dose equivalents
Standard Deviation 17.28
|
SECONDARY outcome
Timeframe: 3 daysPatient knee range of motion was assessed on postoperative days 0, 1 and 2.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo- Comparator
|
Gabapentin
n=20 Participants
Active pain medicine
|
|---|---|---|
|
Knee Range of Motion
Day 0
|
53.12 Degrees
Standard Deviation 17.72
|
57.85 Degrees
Standard Deviation 17.70
|
|
Knee Range of Motion
Day 1
|
66.81 Degrees
Standard Deviation 20.54
|
62.74 Degrees
Standard Deviation 19.44
|
|
Knee Range of Motion
Day 2
|
67.47 Degrees
Standard Deviation 23.13
|
65.94 Degrees
Standard Deviation 15.20
|
SECONDARY outcome
Timeframe: 3 daysPercentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo- Comparator
|
Gabapentin
n=20 Participants
Active pain medicine
|
|---|---|---|
|
Patient Restfulness
Day 0
|
35.3 Percent(%) of participants
|
55.0 Percent(%) of participants
|
|
Patient Restfulness
Day 1
|
52.9 Percent(%) of participants
|
75.0 Percent(%) of participants
|
|
Patient Restfulness
Day 2
|
58.5 Percent(%) of participants
|
65.0 Percent(%) of participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Gabapentin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=17 participants at risk
placebo comparator
|
Gabapentin
n=20 participants at risk
Active pain control medicine
|
|---|---|---|
|
Gastrointestinal disorders
Postoperative illeus
|
5.9%
1/17 • Number of events 1 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
5.0%
1/20 • Number of events 1 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
|
Renal and urinary disorders
Traumatic foley insertion
|
0.00%
0/17 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
5.0%
1/20 • Number of events 1 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
|
Cardiac disorders
Bradycardia and vasovagal syncope
|
5.9%
1/17 • Number of events 1 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
0.00%
0/20 • AE data was collected through the completion of 2 weeks post op visit unless an AE to follow
|
Other adverse events
Adverse event data not reported
Additional Information
Nancy Swinford
Texas Tech University Health Sciences Center
Phone: 806-743-2569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place