NCT01323179

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

March 24, 2011

Last Update Submit

June 4, 2013

Conditions

Postoperative Pain

Keywords

Postoperative painPostoperative opioid requirements

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain during ambulation and at rest

    24 hours

Secondary Outcomes (2)

  • Pain

    7 days

  • Opioid consumption

    7 days

Study Arms (3)

Strong opioids

Patients taking strong opioids preoperatively

Weak opioids

Patients taking weak opioids preoperatively

Opioid native

Patients not taking opioids preoperatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated with elective, primary, unilateral total knee artroplasty (TKA).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dep. of ortopedic surgery, Gentofte Hospital

Hellerup, Hellerup, 2900, Denmark

Location

Dep. of ortopedic surgery, Regionshospitalet Holstebro

Holstebro, Holstebro, 7500, Denmark

Location

Dep. of Anesthesiology, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Dep. of ortopedic surgery, Vejle Sygehus

Vejle, Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Troels H Lunn, MD

    Dep. of Anesthesiology, Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

DK(4)