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The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative gabapentine, | Experimental | Gabapentine |
|
| sugar pill | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentine | Drug | Gabapentine 600 mg 01 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Pain | Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rioko K Sakata, PhD | Universidade Federal de São Paulo | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Gabapentine, | Gabapentine Gabapentine: Gabapentine 600 mg 01 dose |
| FG001 | Sugar Pill | Placebo group Sugar pill: Sugar pill 01 dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Gabapentine, | Gabapentine Gabapentine: Gabapentine 600 mg 01 dose |
| BG001 | Sugar Pill | Placebo group Sugar pill: Sugar pill 01 dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | gabapentine 51,5 (41 - 59) Sugar pill 52,1 (35 - 70) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity | Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preoperative Gabapentine, | Gabapentine Gabapentine: Gabapentine 600 mg 01 dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rioko K. Sakata | Federal University of São Paulo | 055 11 5084 7463 | riokoks.dcir@epm.br |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000927 | Anticonvulsants |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Sugar pill | Other | Sugar pill 01 dose |
|
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Chronic Pain | Numerical score from 0 to 10 scale: Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain) | Posted | Mean | Standard Deviation | points | 6 months |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sugar Pill | Placebo group Sugar pill: Sugar pill 01 dose | 0 | 20 | 0 | 20 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002241 | Carbohydrates |
| 2h after |
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| 2 weeks after |
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| 1 month after |
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| 3 months after |
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| 6 months after |
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