Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Early Mobilization After Total Knee Arthroplasty

This study has been completed.
Information provided by (Responsible Party):
Andreas Harsten, Region Skane Identifier:
First received: May 20, 2012
Last updated: May 22, 2012
Last verified: May 2012
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
Drug: General Anesthesia
Drug: Neuraxial anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 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"). ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01604382

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andreas Harsten, Head of dept Anesthesiol, M.D., Region Skane Identifier: NCT01604382     History of Changes
Other Study ID Numbers: HLM-2012-CPH 
Study First Received: May 20, 2012
Last Updated: May 22, 2012
Health Authority: Sweden: Institutional Review Board

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General processed this record on October 21, 2016