Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Escitalopram; Drug: Placebo

• Registration Number: NCT01430520
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain	At 24 hour	Pain during walking at 24 hour after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Vejle Sygehus; 🇩🇰 Vejle, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark

Regionshospitalet Holstebro; 🇩🇰 Holstebro, Denmark