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
  Purpose

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 Intervention
Arthroplasty, Replacement, Knee
Procedure: femoral nerve block
Procedure: knee infiltration and injection via catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • pain, by numeric rating scale
  • pain, by consumption of analgesics
  • side effects
  • return of function

Estimated Enrollment: 80
Study Start Date: February 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00269529

Locations
Denmark
Aarhus Hospital, Tage Hansens Gade
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
Aarhus University Hospital
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00269529     History of Changes
Other Study ID Numbers: 20050003
Study First Received: December 22, 2005
Last Updated: October 12, 2006
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on August 19, 2014