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Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01430520
First received: September 7, 2011
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
 Drug: Escitalopram
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: At 24 hour ] [ Designated as safety issue: No ]
    Pain during walking at 24 hour after surgery


Secondary Outcome Measures:
  • Pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Pain at rest and during walking the first week after TKA

  • Cumulated pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Cumulated pain scores for pain the first week after TKA

  • Amount of rescue analgesic [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Amount of rescue analgesic the first week after TKA

  • Side effects [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Side effects the first week after TKA

  • anxiety, depression, and sleep quality [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Anxiety, depression, and sleep quality - questionnaire - the first week after TKA

  • Escitalopram level in blood-sample [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Escitalopram level in blood-sample 48 hours after surgery


Enrollment: 120
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Escitalopram Drug: Escitalopram
Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery
Other Name: Cipralex
Placebo Comparator: Placebo Drug: Placebo
Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430520

Locations
Denmark
Gentofte Hospital
Gentofte, Hellerup, Denmark, 2900
Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Vejle Sygehus
Vejle, Denmark, 7100
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, PHD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01430520     History of Changes
Other Study ID Numbers: THL-04-11, 2011-002034-38, H-3-2011-055
Study First Received: September 7, 2011
Last Updated: June 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Dexetimide
Citalopram
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
 Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on June 18, 2013