Back to results

Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Escitalopram

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gentofte Hospital
Regionshospitalet Holstebro
Vejle Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Escitalopram

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain

Pain during walking at 24 hour after surgery

Secondary Outcome Measures

Pain

Pain at rest and during walking the first week after TKA

Cumulated pain scores

Cumulated pain scores for pain the first week after TKA

Amount of rescue analgesic

Amount of rescue analgesic the first week after TKA

Side effects

Side effects the first week after TKA

anxiety, depression, and sleep quality

Anxiety, depression, and sleep quality - questionnaire - the first week after TKA

Escitalopram level in blood-sample

Escitalopram level in blood-sample 48 hours after surgery

Full Information

NCT ID

NCT01430520

First Posted

September 7, 2011

Last Updated

June 4, 2013

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01430520

Brief Title

Analgesic Effect of Escitalopram in Total Knee Arthroplasty (TKA)

Official Title

Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Escitalopram

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Cipralex

Intervention Description

Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery

Primary Outcome Measure Information:

Title

Pain

Description

Pain during walking at 24 hour after surgery

Time Frame

At 24 hour

Secondary Outcome Measure Information:

Title

Pain

Description

Pain at rest and during walking the first week after TKA

Time Frame

1 week

Title

Cumulated pain scores

Description

Cumulated pain scores for pain the first week after TKA

Time Frame

1 week

Title

Amount of rescue analgesic

Description

Amount of rescue analgesic the first week after TKA

Time Frame

1 week

Title

Side effects

Description

Side effects the first week after TKA

Time Frame

1 week

Title

anxiety, depression, and sleep quality

Description

Anxiety, depression, and sleep quality - questionnaire - the first week after TKA

Time Frame

1 week

Title

Escitalopram level in blood-sample

Description

Escitalopram level in blood-sample 48 hours after surgery

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials: