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

Total Knee Replacement Clinical Trial

— TKR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910013
• Other study ID #: PEJ-340
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 28, 2009
• Last updated: February 25, 2011
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: May 2009
• Source: Hopital de l'Enfant-Jesus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Drug:
• Ropivacaine
0.5% intra-articular ropivacaïne (20cc)

Locations

Country	Name	City	State
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic consumption per 24 hours after surgery (mg/kg)		48 hours	No
Secondary	VAS score at 24 hours		48 hours	No