Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01323179
First received: March 24, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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


Condition
Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain during ambulation and at rest


Secondary Outcome Measures:
  • Pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Pain during ambulation and at rest

  • Opioid consumption [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Strong opioids
Patients taking strong opioids preoperatively
Weak opioids
Patients taking weak opioids preoperatively
Opioid native
Patients not taking opioids preoperatively

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323179

Locations
Denmark
Dep. of Anesthesiology, Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Dep. of ortopedic surgery, Gentofte Hospital
Hellerup, Denmark, 2900
Dep. of ortopedic surgery, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Dep. of ortopedic surgery, Vejle Sygehus
Vejle, Denmark, 7100
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Troels H Lunn, MD Dep. of Anesthesiology, Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01323179     History of Changes
Other Study ID Numbers: 11123111
Study First Received: March 24, 2011
Last Updated: June 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Postoperative pain
Postoperative opioid requirements

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics, Opioid
Analgesics, Non-Narcotic
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014