Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT01430520

THL-04-11

H-3-2011-055 (Registry Identifier)

2011-002034-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Escitalopram

Active Comparator group

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo