Analgesic Effect of Escitalopram in Total Knee Arthroplas... | NCT01430520

Studies
Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

NCT01430520

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jun 5, 2013Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Escitalopram
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-002034-38	EudraCT Number
H-3-2011-055	Registry Identifier	Ethics Committee

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 7, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2013

Last Update Posted Date

Jun 5, 2013Estimated

Name	Class
Lundbeck Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Escitalopram	Active Comparator		Drug: Escitalopram
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery	Escitalopram

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pain	Pain at rest and during walking the first week after TKA	1 week
Cumulated pain scores	Cumulated pain scores for pain the first week after TKA

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torben B Hansen, MD	Regionshospitalet Holstebro	Principal Investigator
Henrik Kehlet, MD	Rigshospitalet, Denmark	Study Director
Per W Kristensen, MD	Vejle Sygehus	Principal Investigator
Søren Solgaard, MD	Gentofte Hospital	Principal Investigator
Vibe G Frøkjær, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital		Gentofte Municipality	Hellerup	2900	Denmark
Regionshospitalet Holstebro

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D003909	Dexetimide

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided