NCT01546077

Brief Summary

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

February 3, 2012

Last Update Submit

November 9, 2012

Conditions

Foot Surgery

Outcome Measures

Primary Outcomes (1)

  • consumption of local anesthetics

    36 hours PO

Secondary Outcomes (1)

  • pain scores

    36 hours postoperatively

Study Arms (2)

Hydrolocalization technique group

ACTIVE COMPARATOR

Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound

Procedure: Placement of perineural catheters with Hydrolocalization technique using

Stimulating Catheter technique group

ACTIVE COMPARATOR

A technique for placement of popliteal catheter with the aid of a neurostimulator

Procedure: Placement of perineural catheters with Hydrolocalization technique using

Interventions

Placement of perineural catheters with Hydrolocalization technique usingPROCEDURE

Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group

Hydrolocalization technique groupStimulating Catheter technique group

Eligibility Criteria

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

You may qualify if:

  • adults
  • BMI less than 30

You may not qualify if:

  • known allergies to local anesthetics or other drugs used
  • patient refusal
  • any local or systemic contraindication to the use of popliteal block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Attikon Hospital

Athens, Greece

RECRUITING

Policlinico Tor Vergata

Rome, Italy

RECRUITING

Related Publications (1)

  • Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.

    PMID: 22088876BACKGROUND

Study Officials

  • Tatiana F Sidiropoulou, MD, PhD

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

  • Theodosios Saranteas, MD, PhD

    Attikon Hospital

    PRINCIPAL INVESTIGATOR

  • Georgia G Kostopanagiotou, MD, PhD

    Attikon Hospital

    STUDY CHAIR

Central Study Contacts

Tatiana F Sidiropoulou, MD, PhD

CONTACT

00302105832371tatianasid@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Anesthesiology

Study Record Dates

First Submitted

February 3, 2012

First Posted

March 7, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

IT(1)GR(1)