Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study - Full Text View

Sponsors and Collaborators:	University of Aarhus The Danish Medical Research Council Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00269529

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

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

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

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

Study ID Numbers:	20050003
Study First Received:	December 22, 2005
Last Updated:	October 12, 2006
ClinicalTrials.gov Identifier:	NCT00269529 History of Changes
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

Study placed in the following topic categories:

Anesthetics
Pain
Anesthetics, Local
Pain, Postoperative

ClinicalTrials.gov processed this record on May 06, 2009