Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

NCT ID: NCT01507363

Last Updated: 2014-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed 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.

Conditions

Postoperative Pain; Postoperative Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin "high"

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

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

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

Gabapentin "intermediate"

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

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Gabapentin

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

Intervention Type: DRUG

Gabapentin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Troels Haxholdt Lunn

MD, principal and koordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torben B Hansen B Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Regionshospitalet Holstebro

Henrik Kehlet, MD

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Jørgen B Dahl, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Per W Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Vejle Sygehus

Henrik Husted, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Søren Solgaard, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Mogens B Laursen, MD, Phd.

Role: PRINCIPAL_INVESTIGATOR

Aalborg Sygehus

Lars Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Sygehus

Locations

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

Countries

Denmark

Other Identifiers

2011-003105-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-4-2011-082

Identifier Type: REGISTRY

Identifier Source: secondary_id

THL-06-11

Identifier Type: -

Identifier Source: org_study_id