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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:

Pain

Cumulated 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

Page last updated: August 23, 2015

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