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CompletedNCT01323179Updated Jun 5, 2013

Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

An observational study in Postoperative Pain, sponsored by Hvidovre University Hospital. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Hvidovre University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Postoperative Pain

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Keywords

  • Postoperative pain
  • Postoperative opioid requirements
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 140 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (actual)

Groups and cohorts

  • Strong opioids

    Patients taking strong opioids preoperatively

  • Weak opioids

    Patients taking weak opioids preoperatively

  • Opioid native

    Patients not taking opioids preoperatively

06

What researchers measure

Primary outcomes

  1. Pain

    Pain during ambulation and at rest

    Time frame: 24 hours

Secondary outcomes

  1. Pain

    Pain during ambulation and at rest

    Time frame: 7 days

  2. Opioid consumption

    Time frame: 7 days

07

Study locations

4 sites
  • Dep. of Anesthesiology, Hvidovre University Hospital
    Copenhagen, Hvidovre 2650, Denmark
  • Dep. of ortopedic surgery, Gentofte Hospital
    Hellerup, 2900, Denmark
  • Dep. of ortopedic surgery, Regionshospitalet Holstebro
    Holstebro, 7500, Denmark
  • Dep. of ortopedic surgery, Vejle Sygehus
    Vejle, 7100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01323179
Lead sponsor
Hvidovre University Hospital
Responsible party
Troels Haxholdt Lunn (MD, Hvidovre University Hospital) — Principal investigator
First posted
Mar 25, 2011
Start date
Mar 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jun 5, 2013

Study contacts

Troels H Lunn, MD
principal investigator · Dep. of Anesthesiology, Hvidovre University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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