Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Sedation; Postoperative Pain

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01507363

H-4-2011-082 (Registry Identifier)

2011-003105-22 (EudraCT Number)

THL-06-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary, unilateral total knee arthroplasty (TKA)
• Age 50-85 years
• Ethnic Danes

Exclusion criteria

• Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
• History of depression or mania
• History of alcohol or drug abuse
• History of malignancy
• History of epilepsia
• BMI > 40
• Disease affecting central or peripheral nerve function
• History of dementia
• History of renal insufficiency
• Allergy to Gabapentin
• Women with menstruation (last 2 years)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Gabapentin "high"

Active Comparator group

Description:

Tables with Gabapentin (1300 mg/day) for 7 days, starting on the day of surgery

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Gabapentin "intermediate"

Active Comparator group

Description:

Tables with Gabapentin for 7 days (900 mg/day), starting on the day of surgery

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Placebo tablets for 7 days, starting on the day of surgery

Treatment:

Drug: Placebo