Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00269529
First received: December 22, 2005
Last updated: October 12, 2006
Last verified: October 2006

December 22, 2005
October 12, 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 ClinicalTrials.gov 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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00269529
20050003
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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