Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram<br> | Drug: Escitalopram<br>* Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery<br>* Other names: Cipralex;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain during walking at 24 hour after surgery | At 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain at rest and during walking the first week after TKA | 1 week | 
| Cumulated pain scores | Cumulated pain scores for pain the first week after TKA | 1 week | 
| Amount of rescue analgesic | Amount of rescue analgesic the first week after TKA | 1 week | 
| Side effects | Side effects the first week after TKA | 1 week | 
| anxiety, depression, and sleep quality | Anxiety, depression, and sleep quality - questionnaire - the first week after TKA | 1 week | 
| Escitalopram level in blood-sample | Escitalopram level in blood-sample 48 hours after surgery | 48 hours |