Trial Outcomes & Findings for Preoperative Gabapentine for Carpal Tunnel (NCT NCT01632215)
NCT ID: NCT01632215
Last Updated: 2019-03-05
Results Overview
Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Preoperative Gabapentine,
Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose
|
Sugar Pill
Placebo group
Sugar pill: Sugar pill 01 dose
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Gabapentine for Carpal Tunnel
Baseline characteristics by cohort
| Measure |
Preoperative Gabapentine,
n=20 Participants
Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose
|
Sugar Pill
n=20 Participants
Placebo group
Sugar pill: Sugar pill 01 dose
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
n=5 Participants
|
52.1 years
n=7 Participants
|
51.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumerical score from 0 to 10; zero means no pain and 10 is the more intense pain
Outcome measures
| Measure |
Preoperative Gabapentine,
n=18 Participants
Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose
|
Sugar Pill
n=19 Participants
Placebo group
Sugar pill: Sugar pill 01 dose
|
|---|---|---|
|
Pain Intensity
|
0.3 units on a scale
Standard Deviation 0.8
|
0.4 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 6 monthsNumerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)
Outcome measures
| Measure |
Preoperative Gabapentine,
n=20 Participants
Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose
|
Sugar Pill
n=20 Participants
Placebo group
Sugar pill: Sugar pill 01 dose
|
|---|---|---|
|
Chronic Pain
1 month after
|
3.2 points
Standard Deviation 3.3
|
3.6 points
Standard Deviation 3.4
|
|
Chronic Pain
6 months after
|
1.3 points
Standard Deviation 2.9
|
1.2 points
Standard Deviation 2.2
|
|
Chronic Pain
30 minutes after surgery
|
5.5 points
Standard Deviation 2.7
|
6.9 points
Standard Deviation 2.5
|
|
Chronic Pain
1 hour after surgery
|
2.4 points
Standard Deviation 1.6
|
3.4 points
Standard Deviation 2.9
|
|
Chronic Pain
2h after
|
0.3 points
Standard Deviation 0.8
|
0.6 points
Standard Deviation 1.0
|
|
Chronic Pain
2 weeks after
|
3.6 points
Standard Deviation 3.4
|
4.6 points
Standard Deviation 3.1
|
|
Chronic Pain
3 months after
|
1.8 points
Standard Deviation 3.0
|
1.6 points
Standard Deviation 2.7
|
Adverse Events
Preoperative Gabapentine,
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
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
Dr. Rioko K. Sakata
Federal University of São Paulo
Phone: 055 11 5084 7463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place