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Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00632580
First received: February 28, 2008
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraartikulær Versus ekstraartikulær Bolus Injektion Med Ropivacain Ved Total knæalloplastik: et Prospektivt, Randomiseret, Dobbeltblindet, Kontrolleret Studie

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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
Active Comparator: 1
intraarticular injection with local anesthetic
 Drug: intraarticular injection with ropivacaine
Experimental: 2
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

No publications provided

Responsible Party: Hvidovre University Hospital, Department of Anesthesia
ClinicalTrials.gov Identifier: NCT00632580     History of Changes
Other Study ID Numbers: H-D-2007-0079
Study First Received: February 28, 2008
Last Updated: March 17, 2009
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Pain, Postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013