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Femoral Block With or Without Ropivacaine for Analgesia After Total Knee Replacement (TKR) (TKR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00910013
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

Total knee replacement is a painful procedure. Many solutions have been proposed to diminish the post-operative doses of narcotics, including nerve blocks.

The purpose of the study is to compare if the adjunction of intra-articular ropivacaine to a femoral block is more effective on narcotics consumption than the block alone after TKR.


Condition or disease Intervention/treatment Phase
Total Knee Replacement Drug: Ropivacaine Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the Efficacy on Post-operative Analgesia of Intra-articular Ropivacaine Added to a Femoral Block After Total Knee Replacement
Study Start Date : April 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Ropivacaine + femoral block
After the surgery is proceeded and after the closure of the joint capsule, 20 cc of ropivacaine 0.5% is inserted intra-articular through a catheter.
Drug: Ropivacaine
0.5% intra-articular ropivacaïne (20cc)


Outcome Measures

Primary Outcome Measures :
  1. Narcotic consumption per 24 hours after surgery (mg/kg) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. VAS score at 24 hours [ 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:

  • Primary total knee replacement
  • Age > 18 years old
  • Accept the study

Exclusion Criteria:

  • Revision surgery
  • Use of anticoagulants drugs
  • Neurologic disorder
  • Unable to sign consent form
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): NCT00910013


Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus
Québec, Quebec, Canada, G1J1Z4
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: Dr Stéphane Pelet, MD,PhD Hôpital Enfant-Jésus
More Information

Responsible Party: Dr Stéphane Pelet, MD, PhD, Département orthopédie, CHA-Pavillon Enfant-Jésus
ClinicalTrials.gov Identifier: NCT00910013     History of Changes
Other Study ID Numbers: PEJ-340
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: May 2009

Keywords provided by Hopital de l'Enfant-Jesus:
TKR
Femoral block
Ropivacaïne
intra-articular ropivacaïne
post-operative analgesia

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents