Intra- vs. Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty: a Randomized, Double-Blind Study - Full Text View

Intra- vs. Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty: a Randomized, Double-Blind Study

This study is currently recruiting participants.
Verified by Hvidovre University Hospital, February 2008

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00632580

Purpose

The purpose of this study is to evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.

Condition	Intervention	Phase
Pain, Postoperative	Drug: intraarticular injection with ropivacaine Drug: extraarticular injection with ropivacaine	Phase IV

MedlinePlus related topics:

Anesthesia Knee Replacement

ChemIDplus related topics:

Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Intraartikulær Versus ekstraartikulær Bolus Injektion Med Ropivacain Ved Total knæalloplastik: et Prospektivt, Randomiseret, Dobbeltblindet, Kontrolleret Studie

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator intraarticular injection with local anesthetic	Drug: intraarticular injection with ropivacaine
2: Experimental intracapsular injection with local anesthetic	Drug: extraarticular injection with ropivacaine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

eligible for elective total knee arthroplasty
able to speak and understand Danish
able to give informed consent

Exclusion Criteria:

alocohol or medical abuse
allergies to local anesthetics
age < 18 yrs.
intolerance to opioids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632580

Locations


Denmark
	Hvidovre University Hospital	Recruiting
	Copenhagen, Denmark, 2650
	Contact: Lasse Andersen, MD +45 36323125 lasse.oestergaard.andersen@hvh.regionh.dk
	Principal Investigator: Lasse Andersen, MD

Sponsors and Collaborators

Hvidovre University Hospital

Investigators


Principal Investigator:	Lasse Andersen, MD	Hvidovre University Hospital

More Information

Responsible Party:	Department of Anesthesia ( Hvidovre University Hospital )
Study ID Numbers:	H-D-2007-0079
First Received:	February 28, 2008
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00632580
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:

Pain, Postoperative

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Complications

Ropivacaine

Pain

Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Peripheral Nervous System Agents

Central Nervous System Agents

Pharmacologic Actions

Anesthetics, Local

ClinicalTrials.gov processed this record on September 19, 2008