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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014