Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Postoperative Pain Clinical Trial

Official title:

Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430520
• Other study ID #: THL-04-11
• Secondary ID: 2011-002034-38H-
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2011
• Last updated: June 4, 2013
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Gentofte	Hellerup
Denmark	Regionshospitalet Holstebro	Holstebro
Denmark	Vejle Sygehus	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain during walking at 24 hour after surgery	At 24 hour	No
Secondary	Pain	Pain at rest and during walking the first week after TKA	1 week	No
Secondary	Cumulated pain scores	Cumulated pain scores for pain the first week after TKA	1 week	No
Secondary	Amount of rescue analgesic	Amount of rescue analgesic the first week after TKA	1 week	No
Secondary	Side effects	Side effects the first week after TKA	1 week	Yes
Secondary	anxiety, depression, and sleep quality	Anxiety, depression, and sleep quality - questionnaire - the first week after TKA	1 week	No
Secondary	Escitalopram level in blood-sample	Escitalopram level in blood-sample 48 hours after surgery	48 hours	No