Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery

Interventions

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Escitalopram

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

Intervention Type DRUG

Placebo

Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery

Intervention Type DRUG

Other Intervention Names

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Cipralex

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No