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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003105-22 | EudraCT Number | ||
| H-4-2011-082 | Registry Identifier | Ethics Committee |
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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.
Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin "high" | Active Comparator | Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery |
|
| Gabapentin "intermediate" | Active Comparator | Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery |
|
| Placebo | Placebo Comparator | Placebo tablets for 7 days, starting on the day of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm) | At 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation | Sedation at 6 hours, numeric range scale (NRS, 0-10) | At 6 hours |
| Pain | Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben B Hansen B Hansen, MD | Regionshospitalet Holstebro | Principal Investigator |
| Henrik Kehlet, MD | Rigshospitalet, Denmark | Study Director |
| Jørgen B Dahl, MD | Rigshospitalet, Denmark | Principal Investigator |
| Per W Kristensen, MD | Vejle Sygehus | Principal Investigator |
| Henrik Husted, MD | Hvidovre University Hospital | Principal Investigator |
| Søren Solgaard, MD | Gentofte Hospital | Principal Investigator |
| Mogens B Laursen, MD, Phd. | Aalborg Sygehus | Principal Investigator |
| Lars Hansen, MD | Esbjerg Sygehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of ortopedic surgery, Aalborg Sygehus | Aalborg | Aalborg | 9000 | Denmark | ||
| Dep. of ortopedic surgery, Esbjerg Sygehus |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Gabapentin | Drug | Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery |
|
| Placebo | Drug | Placebo tablets for 7 days, starting on the day of surgery |
|
| 1 week |
| Cumulated pain scores | Cumulated pain scores for pain the first week after TKA | 1 week |
| Amount of rescue analgesic | Amount of rescue analgesic the first week after TKA, mg | 1 week |
| Side effects | Side effects the first week after TKA | 1 week |
| Cumulated side effects scores | Cumulated side effects scores the first week after TKA | 1 week |
| Amount of ondansetron and sleeping medicine | Amount of ondansetron and sleeping medicine the first week after TKA, mg | 1 week |
| Anxiety and depression | Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale | 1 week |
| Gabapentin level in blood-sample | Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration | 1 Day |
| Esbjerg |
| Esbjerg |
| 6700 |
| Denmark |
| Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital | Copenhagen | Hvidovre | Denmark |
| 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 |