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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01430520
Enrollment
120
Registered
2011-09-08
Start date
2011-09-30
Completion date
2013-05-31
Last updated
2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGEscitalopram

Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery

DRUGPlacebo

Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery

Sponsors

Lundbeck Foundation
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PainAt 24 hourPain during walking at 24 hour after surgery

Secondary

MeasureTime frameDescription
Cumulated pain scores1 weekCumulated pain scores for pain the first week after TKA
Amount of rescue analgesic1 weekAmount of rescue analgesic the first week after TKA
Pain1 weekPain at rest and during walking the first week after TKA
anxiety, depression, and sleep quality1 weekAnxiety, depression, and sleep quality - questionnaire - the first week after TKA
Escitalopram level in blood-sample48 hoursEscitalopram level in blood-sample 48 hours after surgery
Side effects1 weekSide effects the first week after TKA

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026