NCT00910013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

February 28, 2011

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

May 28, 2009

Last Update Submit

February 25, 2011

Conditions

Total Knee Replacement

Keywords

TKRFemoral blockRopivacaïneintra-articular ropivacaïnepost-operative analgesia

Outcome Measures

Primary Outcomes (1)

  • Narcotic consumption per 24 hours after surgery (mg/kg)

    48 hours

Secondary Outcomes (1)

  • VAS score at 24 hours

    48 hours

Study Arms (1)

Ropivacaine + femoral block

EXPERIMENTAL

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

Interventions

RopivacaineDRUG

0.5% intra-articular ropivacaïne (20cc)

Ropivacaine + femoral block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J1Z4, Canada

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dr Stéphane Pelet, MD,PhD

    Hôpital Enfant-Jésus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

April 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 28, 2011

Record last verified: 2009-05

Locations

CA(1)