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Early Mobilization After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Harsten, Region Skane
ClinicalTrials.gov Identifier:
NCT01604382
First received: May 20, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

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
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:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 16, 2013