Placement of Perineural Catheters in the Popliteal Region

November 9, 2012 updated by: Sidiropoulou Tatiana, Attikon Hospital

Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Attikon Hospital
        • Principal Investigator:
          • Tatiana F Sidiropoulou, MD, PhD
        • Principal Investigator:
          • Theodosios Saranteas, MD, PhD
  • Italy
      • Rome, Italy
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
        • Principal Investigator:
          • Mario Dauri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults
  • BMI less than 30

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydrolocalization technique group
Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound
Procedure: Placement of perineural catheters with Hydrolocalization technique using
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
Active Comparator: Stimulating Catheter technique group
A technique for placement of popliteal catheter with the aid of a neurostimulator
Procedure: Placement of perineural catheters with Hydrolocalization technique using
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
consumption of local anesthetics
Time Frame: 36 hours PO
36 hours PO

Secondary Outcome Measures

Outcome Measure
Time Frame
pain scores
Time Frame: 36 hours postoperatively
36 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Investigators

  • Principal Investigator: Tatiana F Sidiropoulou, MD, PhD, Attikon Hospital
  • Principal Investigator: Theodosios Saranteas, MD, PhD, Attikon Hospital
  • Study Chair: Georgia G Kostopanagiotou, MD, PhD, Attikon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HLOCSTIM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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