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NCT Number: NCT01507363

Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Sedation Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dep. of ortopedic surgery, Aalborg Sygehus, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gabapentin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pain

    Time frame: At 24 hour

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

Secondary outcomes

  1. Sedation

    Time frame: At 6 hours

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

  2. Pain

    Time frame: 1 week

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

  3. Cumulated pain scores

    Time frame: 1 week

    Cumulated pain scores for pain the first week after TKA

  4. Amount of rescue analgesic

    Time frame: 1 week

    Amount of rescue analgesic the first week after TKA, mg

  5. Side effects

    Time frame: 1 week

    Side effects the first week after TKA

  6. Cumulated side effects scores

    Time frame: 1 week

    Cumulated side effects scores the first week after TKA

  7. Amount of ondansetron and sleeping medicine

    Time frame: 1 week

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

  8. Anxiety and depression

    Time frame: 1 week

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

  9. Gabapentin level in blood-sample

    Time frame: 1 Day

    Gabapentin level in blood-sample at 12 am on the first day after surgery, serum-koncentration

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2012
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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