Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
3 other identifiers
interventional
120
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 postoperative-pain
Started Sep 2011
Typical duration for phase_4 postoperative-pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 5, 2013
June 1, 2013
1.6 years
September 7, 2011
June 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
Pain during walking at 24 hour after surgery
At 24 hour
Secondary Outcomes (6)
Pain
1 week
Cumulated pain scores
1 week
Amount of rescue analgesic
1 week
Side effects
1 week
anxiety, depression, and sleep quality
1 week
- +1 more secondary outcomes
Study Arms (2)
Escitalopram
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery
Eligibility Criteria
You may qualify if:
- Primary, unilateral total knee arthroplasty (TKA)
- Age \> 18 \> 81
- Ethnic Danes
- Score \> 20 on Pain Catastrophising Scale
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Lundbeck Foundationcollaborator
Study Sites (3)
Gentofte Hospital
Gentofte Municipality, Hellerup, 2900, Denmark
Regionshospitalet Holstebro
Holstebro, Holstebro, 7500, Denmark
Vejle Sygehus
Vejle, Vejle, 7100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torben B Hansen, MD
Regionshospitalet Holstebro
- STUDY DIRECTOR
Henrik Kehlet, MD
Rigshospitalet, Denmark
- PRINCIPAL INVESTIGATOR
Per W Kristensen, MD
Vejle Sygehus
- PRINCIPAL INVESTIGATOR
Søren Solgaard, MD
Gentofte Hospital
- PRINCIPAL INVESTIGATOR
Vibe G Frøkjær, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PHD
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 8, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
June 5, 2013
Record last verified: 2013-06