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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Procedure: femoral nerve block Procedure: knee infiltration and injection via catheter Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Primary Outcome Measures :
  1. pain, by numeric rating scale
  2. pain, by consumption of analgesics
  3. side effects
  4. return of function

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00269529

Aarhus Hospital, Tage Hansens Gade
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
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 Identifier: NCT00269529     History of Changes
Other Study ID Numbers: 20050003
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: October 13, 2006
Last Verified: October 2006

Keywords provided by University of Aarhus:
postoperative pain
knee arthroplasty
femoral nerve block