Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study

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. Identifier: NCT00269529
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : October 13, 2006
The Danish Medical Research Council
Aarhus University Hospital
Information provided by:
University of Aarhus

December 22, 2005
December 23, 2005
October 13, 2006
February 2005
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  • pain, by numeric rating scale
  • pain, by consumption of analgesics
  • side effects
  • return of function
Same as current
Complete list of historical versions of study NCT00269529 on Archive Site
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Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study
Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.
The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.
Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
  • Procedure: femoral nerve block
  • Procedure: knee infiltration and injection via catheter
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
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Inclusion Criteria:

  • patients planned for primary total knee arthroplasty due to primary arthrosis

Exclusion Criteria:

  • Patients unable to provide informed consent
  • patients with contraindications for spinal anesthesia
  • patients with known hypersensitivity towards the used drugs
  • patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated
  • patients who have undergone major bone surgery in the knee to be operated
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
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University of Aarhus
  • The Danish Medical Research Council
  • Aarhus University Hospital
Principal Investigator: Else Tønnesen, Professor Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark
Principal Investigator: Kjeld Søballe, Professor Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
University of Aarhus
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP