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Completed

NCT Number: NCT01430520

Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. The investigators therefore investigate the effect of Escitalopram 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 Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte Hospital, Gentofte Municipality, Hellerup, Denmark

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About this study

Pain is a major problem after TKA, especially in patients with high pain catastrophizing. Newer MR-scan studies indicate that Escitalopram may have an immediate cognitive and emotional effect. Patients with high pain catastrophizing are mentally vulnerable and may be sensitive to the effects of Escitalopram.

We therefore investigate the effect of Escitalopram as a perioperative analgesic in this group of patients where the pain problem is pronounced.

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 > 18 > 81
  • Ethnic Danes
  • Score > 20 on Pain Catastrophising Scale

Exclusion criteria

  • Medication that causes risk in combination with SSRI (6 month)
  • Treatment for anxiety or depression
  • History of depression or mania
  • Treatment with systemic glucocorticoids (6 month)
  • Treatment with opioids (4 weeks)
  • Alcohol or drug abuse
  • History of malignancy
  • Fertile woman
  • History of epilepsia
  • Treatment with anticoagulants
  • BMI > 40
  • Disease affecting central or peripheral nerve function
  • Dementia
  • History of gastrointestinal bleeding
  • History of hepato- or renal insufficiency
  • Allergy to Escitalopram

Treatment and study plan

Escitalopram

Drug

Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery

Other names: Cipralex

Placebo

Drug

Placebo tablets, 1 tablet a day 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

Secondary outcomes

  1. Pain

    Time frame: 1 week

    Pain at rest and during walking the first week after TKA

  2. Cumulated pain scores

    Time frame: 1 week

    Cumulated pain scores for pain the first week after TKA

  3. Amount of rescue analgesic

    Time frame: 1 week

    Amount of rescue analgesic the first week after TKA

  4. Side effects

    Time frame: 1 week

    Side effects the first week after TKA

  5. anxiety, depression, and sleep quality

    Time frame: 1 week

    Anxiety, depression, and sleep quality - questionnaire - the first week after TKA

  6. Escitalopram level in blood-sample

    Time frame: 48 hours

    Escitalopram level in blood-sample 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 8, 2011
Registry last updated
Jun 5, 2013

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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