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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Escitalopram; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Regionshospitalet Holstebro
  • Vejle, Denmark, 7100
    • Vejle Sygehus
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
Active Comparator: Escitalopram	Drug: Escitalopram; Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery; Other Names: Cipralex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain during walking at 24 hour after surgery	At 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated pain scores	Cumulated pain scores for pain the first week after TKA	1 week
Side effects	Side effects the first week after TKA	1 week
Pain	Pain at rest and during walking the first week after TKA	1 week
Amount of rescue analgesic	Amount of rescue analgesic the first week after TKA	1 week
anxiety, depression, and sleep quality	Anxiety, depression, and sleep quality - questionnaire - the first week after TKA	1 week
Escitalopram level in blood-sample	Escitalopram level in blood-sample 48 hours after surgery	48 hours

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Lundbeck Foundation
• Investigators: Study Director: Henrik Kehlet, MD, Rigshospitalet, Denmark; Principal Investigator: Per W Kristensen, MD, Vejle Sygehus; Principal Investigator: Søren Solgaard, MD, Gentofte Hospital; Principal Investigator: Torben B Hansen, MD, Regionshospitalet Holstebro; Principal Investigator: Vibe G Frøkjær, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 7, 2011
• First Posted (Estimate): September 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 5, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: THL-04-11; 2011-002034-38 (EudraCT Number); H-3-2011-055 (Registry Identifier: Ethics Committee)