Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Escitalopram (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hvidovre University Hospital Official(s) and/or principal investigator(s): Torben B Hansen, MD, Principal Investigator, Affiliation: Regionshospitalet Holstebro Henrik Kehlet, MD, Study Director, Affiliation: Rigshospitalet, Denmark Per W Kristensen, MD, Principal Investigator, Affiliation: Vejle Sygehus Søren Solgaard, MD, Principal Investigator, Affiliation: Gentofte Hospital Vibe G Frøkjær, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
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.
Clinical Details
Official title: Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain
Secondary outcome: PainCumulated pain scores Amount of rescue analgesic Side effects anxiety, depression, and sleep quality Escitalopram level in blood-sample
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Regionshospitalet Holstebro, Holstebro 7500, Denmark
Vejle Sygehus, Vejle 7100, Denmark
Gentofte Hospital, Gentofte, Hellerup 2900, Denmark
Additional Information
Starting date: September 2011
Last updated: June 4, 2013
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