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Early Mobilization After Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604382
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andreas Harsten, Region Skane
  Purpose
Patients undergoing elective total knee arthroplasty are randomized to either intrathecal anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce length-of-hospital stay. Outcome variables are postoperative nausea and vomiting, mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.

Condition Intervention
Osteoarthritis Drug: General Anesthesia Drug: Neuraxial anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Whether General or Regional Anesthesia for Patients Undergoing Elective Total Knee Arthroplasty Could Effect Length of Hospital Stay

Resource links provided by NLM:


Further study details as provided by Andreas Harsten, Region Skane:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days"). ]
    Length of hospital stay is defined as teh time from end of surgery until the patient is ready to be discharged


Secondary Outcome Measures:
  • Post operative pain [ Time Frame: measured the first 48 hrs after surgery ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
Receives General Anesthesia as described above
Drug: General Anesthesia
General Anesthesia as described above
Other Names:
  • Propofol
  • Remifentanil
Placebo Comparator: Placebo
Patients receives neuraxial anesthesia as described above
Drug: Neuraxial anesthesia
Neuraxial anesthesia as described above
Other Name: Bupivacaine

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with osteoarthritis scheduled for TKA at the department of orthopedic surgery, Hässleholm Hospital, Sweden, are eligible for participation in the study.

Exclusion Criteria:

  • body mass index (BMI) > 35 m/kg2,
  • prior major knee surgery to the ipsilateral knee,
  • ongoing infection, known immunological deficiency or ASA physical status category > IV.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604382


Locations
Sweden
Lund University, Hässleholm Hospital
Hässleholm, Skane, Sweden, 381 25
Sponsors and Collaborators
Region Skane
Investigators
Study Director: Mads Werner, M.D. PhD Multidisciplinary Pain Center, Copenhagen, Denmark
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Harsten, Head of dept Anesthesiol, M.D., Region Skane
ClinicalTrials.gov Identifier: NCT01604382     History of Changes
Other Study ID Numbers: HLM-2012-CPH
First Submitted: May 20, 2012
First Posted: May 23, 2012
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by Andreas Harsten, Region Skane:
Total Knee Arthroplasty (TKA)

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General