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

This study has been completed.
Sponsor:
Information provided by:
Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT00910013
First received: May 28, 2009
Last updated: February 25, 2011
Last verified: May 2009
  Purpose

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 Intervention Phase
Total Knee Replacement
Drug: Ropivacaine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Narcotic consumption per 24 hours after surgery (mg/kg) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS score at 24 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: May 28, 2009
Last Updated: February 25, 2011
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 30, 2014