Status:

COMPLETED

Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Lead Sponsor:

Hvidovre University Hospital

Collaborating Sponsors:

Lundbeck Foundation

Conditions:

Postoperative Pain

Postoperative Sedation

Eligibility:

All Genders

50-85 years

Phase:

PHASE4

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2013

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT01507363

Start Date

January 1 2012

End Date

November 1 2013

Last Update

April 11 2014

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Dep. of ortopedic surgery, Aalborg Sygehus

Aalborg, Aalborg, Denmark, 9000

2

Dep. of ortopedic surgery, Esbjerg Sygehus

Esbjerg, Esbjerg, Denmark, 6700

3

Dep. of anesthesiology and ortopedic surgery Hvidovre Hospital

Copenhagen, Hvidovre, Denmark