Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

NCT ID: NCT01323179

Last Updated: 2013-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-02-28

Brief Summary

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Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Strong opioids

Patients taking strong opioids preoperatively

No interventions assigned to this group

Weak opioids

Patients taking weak opioids preoperatively

No interventions assigned to this group

Opioid native

Patients not taking opioids preoperatively

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion Criteria

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of glucocorticoids
* Malignancy
* BMI \> 40
* Dementia or other cognitive dysfunction
* Treatment of anxiety or depression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Troels Haxholdt Lunn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Troels H Lunn, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesiology, Hvidovre University Hospital

Locations

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Dep. of ortopedic surgery, Gentofte Hospital

Hellerup, Hellerup, Denmark

Site Status

Dep. of ortopedic surgery, Regionshospitalet Holstebro

Holstebro, Holstebro, Denmark

Site Status

Dep. of Anesthesiology, Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Dep. of ortopedic surgery, Vejle Sygehus

Vejle, Vejle, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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11123111

Identifier Type: -

Identifier Source: org_study_id

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