NCT02451605

Brief Summary

Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 12, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

May 12, 2015

Last Update Submit

May 21, 2015

Conditions

Total Knee Replacement

Keywords

surgery

Outcome Measures

Primary Outcomes (2)

  • Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition

    Pain assessment and evolution in postoperative period (passive condition)

    up to day 7

  • Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)

    Pain assessment and evolution in postoperative period (active condition)

    up to day 7

Secondary Outcomes (3)

  • Postintervention nausea vomiting

    at hour 0, at hours 6, at day 1

  • Patient satisfaction

    at day 1

  • Opioid consumption

    up to 48 hours

Study Arms (3)

Femoral nerve blockade

ACTIVE COMPARATOR

In this group, patient will benefit of an ultrasound guided femoral nerve blockade with continuous catheter infusion as (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.

Drug: Analgesic nerve blockade (Ropivacaine)Procedure: Total knee replacement surgery.

Adductor canal blockade

ACTIVE COMPARATOR

In this group, patient will benefit of an ultrasound guided adductor canal blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for for total knee replacement surgery.

Drug: Analgesic nerve blockade (Ropivacaine)Procedure: Total knee replacement surgery.

Subgluteal sciatic nerve blockade

ACTIVE COMPARATOR

In this group, patient will benefit of an ultrasound guided subgluteal sciatic nerve blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.

Drug: Analgesic nerve blockade (Ropivacaine)Procedure: Total knee replacement surgery.

Interventions

Analgesic nerve blockade (Ropivacaine)DRUG

Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.

Also known as: Regional anesthesia
Adductor canal blockadeFemoral nerve blockadeSubgluteal sciatic nerve blockade
Total knee replacement surgery.PROCEDURE

Total knee replacement surgery.

Adductor canal blockadeFemoral nerve blockadeSubgluteal sciatic nerve blockade

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for total knee replacement surgery.

You may not qualify if:

  • refusal to study,
  • coagulation disorder,
  • infection at the puncture site,
  • preexisting neuropathy,
  • allergy to local anesthetics,
  • renal or hepatocellular insufficiency,
  • context of chronic pain,
  • drugs abuse,
  • pregnant patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University og Liege, University Hospital

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

RopivacaineAnesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesiaAnesthesia and Analgesia

Study Officials

  • Jean-Francois Brichant

    University of Liege

    STUDY CHAIR

Central Study Contacts

Pierre Goffin

CONTACT

003243667178goffin.pjc@gmail.com

Jean-Pierre Lecoq

CONTACT

003243667178jplecoq@chu.ulg.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 22, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

BE(1)