Clinical trial NCT01430520: Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
Official title: Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2011-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: At 24 hour
Secondary outcomes:
measure: Pain
timeFrame: 1 week
measure: Cumulated pain scores
timeFrame: 1 week
measure: Amount of rescue analgesic
timeFrame: 1 week
measure: Side effects
timeFrame: 1 week
measure: anxiety, depression, and sleep quality
timeFrame: 1 week
measure: Escitalopram level in blood-sample
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: Hellerup
city: Holstebro
country: Denmark
facility: Regionshospitalet Holstebro
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Regionshospitalet Holstebro
name: Torben B Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD
role: STUDY_DIRECTOR
affiliation: Vejle Sygehus
name: Per W Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte Hospital
name: Søren Solgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Vibe G Frøkjær, MD
role: PRINCIPAL_INVESTIGATOR
References: