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Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00632580
Recruitment Status : Unknown
Verified March 2009 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : March 10, 2008
Last Update Posted : March 18, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Drug: intraarticular injection with ropivacaine Drug: extraarticular injection with ropivacaine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraartikulær Versus ekstraartikulær Bolus Injektion Med Ropivacain Ved Total knæalloplastik: et Prospektivt, Randomiseret, Dobbeltblindet, Kontrolleret Studie
Study Start Date : January 2008
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. pain [ Time Frame: 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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: Hvidovre University Hospital, Department of Anesthesia
ClinicalTrials.gov Identifier: NCT00632580     History of Changes
Other Study ID Numbers: H-D-2007-0079
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by Hvidovre University Hospital:
Pain, Postoperative

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