Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

Postoperative Pain Clinical Trial

Official title:

Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323179
• Other study ID #: 11123111
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: June 4, 2013
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Denmark	Dep. of Anesthesiology, Hvidovre University Hospital	Copenhagen	Hvidovre
Denmark	Dep. of ortopedic surgery, Gentofte Hospital	Hellerup
Denmark	Dep. of ortopedic surgery, Regionshospitalet Holstebro	Holstebro
Denmark	Dep. of ortopedic surgery, Vejle Sygehus	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain during ambulation and at rest	24 hours	No
Secondary	Pain	Pain during ambulation and at rest	7 days	No
Secondary	Opioid consumption		7 days	No