Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 590 for:    ESCITALOPRAM AND Celexa

Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01430520
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE September 8, 2011
Last Update Posted Date June 5, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2011)
Pain [ Time Frame: At 24 hour ]
Pain during walking at 24 hour after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01430520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2011)
  • Pain [ Time Frame: 1 week ]
    Pain at rest and during walking the first week after TKA
  • Cumulated pain scores [ Time Frame: 1 week ]
    Cumulated pain scores for pain the first week after TKA
  • Amount of rescue analgesic [ Time Frame: 1 week ]
    Amount of rescue analgesic the first week after TKA
  • Side effects [ Time Frame: 1 week ]
    Side effects the first week after TKA
  • anxiety, depression, and sleep quality [ Time Frame: 1 week ]
    Anxiety, depression, and sleep quality - questionnaire - the first week after TKA
  • Escitalopram level in blood-sample [ Time Frame: 48 hours ]
    Escitalopram level in blood-sample 48 hours after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)
Official Title  ICMJE Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Escitalopram
    Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery
    Other Name: Cipralex
  • Drug: Placebo
    Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
Study Arms  ICMJE
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01430520
Other Study ID Numbers  ICMJE THL-04-11
2011-002034-38 ( EudraCT Number )
H-3-2011-055 ( Registry Identifier: Ethics Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Troels Haxholdt Lunn, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Lundbeck Foundation
Investigators  ICMJE
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
PRS Account Hvidovre University Hospital
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP