NCT02419261

Brief Summary

Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.

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 Oct 2014

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.6 years

First QC Date

April 2, 2015

Last Update Submit

March 21, 2018

Conditions

Keywords

knee surgeryanterior cruciate ligament surgerynerve block

Outcome Measures

Primary Outcomes (2)

  • Cold sensitivity assessment (cold, very cold, no sensation)

    sensitivity description (cold, very cold, no sensation)

    From 30 to 60 minutes after nerve blockade

  • Motor blockade assessment (dynamometer)

    motor blockade evaluation with dynamometer

    From 30 to 60 minutes after nerve blockade

Secondary Outcomes (1)

  • Postoperative pain assessment (visual analgesic scale)

    At 2, 4, 6 postoperative hours

Study Arms (2)

Adductor Canal Blockade

ACTIVE COMPARATOR

In this group, patient will benefit of an ultrasound guided adductor canal blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair

Drug: Analgesic nerve blockade (Ropivacaine)Procedure: Arthroscopic surgical repair of the anterior cruciate ligament

Femoral Nerve Blockade

ACTIVE COMPARATOR

In this group, patient will benefit of an ultrasound guided femoral nerve blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair

Drug: Analgesic nerve blockade (Ropivacaine)Procedure: Arthroscopic surgical repair of the anterior cruciate ligament

Interventions

Analgesic nerve blockade for Arthroscopic surgical repair of the anterior cruciate ligament

Adductor Canal BlockadeFemoral Nerve Blockade
Adductor Canal BlockadeFemoral Nerve Blockade

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for anterior cruciate ligament repair

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 of Liege, University Hospital

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jean-Pierre H Lecoq, MD PhD

    University of Liege, University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Pierre H Lecoq, MD PhD

CONTACT

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
MD, PhD

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 17, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations