NCT02006355

Brief Summary

This study aims at comparing continuous local anesthesia and femoral nerve bloc for total knee arthroplasty in terms of post-operative recovery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2017

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

November 27, 2013

Last Update Submit

August 24, 2018

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Discharge ability time period

    Participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (2)

Continuous femoral nerve bloc

ACTIVE COMPARATOR

Continuous femoral nerve bloc

Drug: Ropivacaine

Continuous local anesthesia

EXPERIMENTAL

Continuous local infiltration of local anesthetic in the operated knee.

Drug: Ropivacaine

Interventions

RopivacaineDRUG
Continuous femoral nerve blocContinuous local anesthesia

Eligibility Criteria

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

You may qualify if:

  • Total knee arthroplasty
  • Age \> 18 years with social security covering.
  • Written informed consent

You may not qualify if:

  • Age \< 18 years
  • ASA Physical Status \> III
  • Body weight \< 50 kg
  • Latex or silver allergy.
  • Loco-regional anesthesia contraindication
  • Chronic anticoagulant, corticoid or pain treatment.
  • Rivaroxaban or enoxaparin contraindication
  • Communication issues
  • Patient under guardianship
  • Pregnant or breast-feeding patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCOM-Hôpitaux Universitaires de Strasbourg

Illkirch-Graffenstaden, 67400, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jean-Yves JENNY, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 10, 2013

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

August 12, 2017

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

FR(1)