Carpal Tunnel Syndrome
Conditions
Keywords
gabapentine, postoperative pain
Brief summary
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.
Detailed description
There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery. Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine. The statistical program used for analysis of the results was the Instat Graph
Interventions
DRUGGabapentine
Gabapentine 600 mg 01 dose
OTHERSugar pill
Sugar pill 01 dose
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* carpal tunnel syndrome
Exclusion criteria
* disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 6 months | Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | 6 months | Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preoperative Gabapentine, Gabapentine
Gabapentine: Gabapentine 600 mg 01 dose | 20 |
| Sugar Pill Placebo group
Sugar pill: Sugar pill 01 dose | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Preoperative Gabapentine, | Sugar Pill | Total |
|---|---|---|---|
| Age, Continuous | 51.5 years | 52.1 years | 51.8 years |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pain Intensity
Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Gabapentine, | Pain Intensity | 0.3 units on a scale | Standard Deviation 0.8 |
| Sugar Pill | Pain Intensity | 0.4 units on a scale | Standard Deviation 1.8 |
Secondary
Chronic Pain
Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative Gabapentine, | Chronic Pain | 2h after | 0.3 points | Standard Deviation 0.8 |
| Preoperative Gabapentine, | Chronic Pain | 1 month after | 3.2 points | Standard Deviation 3.3 |
| Preoperative Gabapentine, | Chronic Pain | 1 hour after surgery | 2.4 points | Standard Deviation 1.6 |
| Preoperative Gabapentine, | Chronic Pain | 3 months after | 1.8 points | Standard Deviation 3 |
| Preoperative Gabapentine, | Chronic Pain | 2 weeks after | 3.6 points | Standard Deviation 3.4 |
| Preoperative Gabapentine, | Chronic Pain | 6 months after | 1.3 points | Standard Deviation 2.9 |
| Preoperative Gabapentine, | Chronic Pain | 30 minutes after surgery | 5.5 points | Standard Deviation 2.7 |
| Sugar Pill | Chronic Pain | 6 months after | 1.2 points | Standard Deviation 2.2 |
| Sugar Pill | Chronic Pain | 30 minutes after surgery | 6.9 points | Standard Deviation 2.5 |
| Sugar Pill | Chronic Pain | 1 hour after surgery | 3.4 points | Standard Deviation 2.9 |
| Sugar Pill | Chronic Pain | 2h after | 0.6 points | Standard Deviation 1 |
| Sugar Pill | Chronic Pain | 2 weeks after | 4.6 points | Standard Deviation 3.1 |
| Sugar Pill | Chronic Pain | 1 month after | 3.6 points | Standard Deviation 3.4 |
| Sugar Pill | Chronic Pain | 3 months after | 1.6 points | Standard Deviation 2.7 |
p-value: <0.05t-test, 1 sided