Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Hvidovre University Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Postoperative Pain Postoperative Sedation

Interventions

GabapentinDRUG

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

GabapentinDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (3)

Dep. of ortopedic surgery, Aalborg Sygehus

Aalborg, Aalborg, Denmark

Dep. of ortopedic surgery, Esbjerg Sygehus

Esbjerg, Esbjerg, Denmark

Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Outcomes

Primary Outcomes

Pain

Pain during walking at 24 hour after surgery, visuel analog scale (VAS, 0-100 mm)

Time frame: At 24 hour

Secondary Outcomes

Sedation

Sedation at 6 hours, numeric range scale (NRS, 0-10)

Time frame: At 6 hours

Pain

Pain at rest and during walking the first week after TKA, visuel analog scale (VAS, 0-100 mm)

Time frame: 1 week

Cumulated pain scores

Cumulated pain scores for pain the first week after TKA

Time frame: 1 week

Amount of rescue analgesic

Amount of rescue analgesic the first week after TKA, mg

Time frame: 1 week

Side effects

Side effects the first week after TKA

Time frame: 1 week

Cumulated side effects scores

Cumulated side effects scores the first week after TKA

Time frame: 1 week

Amount of ondansetron and sleeping medicine

Amount of ondansetron and sleeping medicine the first week after TKA, mg

Time frame: 1 week

Anxiety and depression

Anxiety and depression - questionnaire - the first week after TKA, Hospitality and Anxiety and Depression Scale

Data from ClinicalTrials.gov

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