Comparison of Two Techniques for Placement of Perineural Femoral Catheters. (HLOCSTIM2)

November 13, 2012 updated by: Sidiropoulou Tatiana, Attikon Hospital

Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.

Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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: HLOC
Placement of a femoral catheter with the hydrolocalization technique
Procedure: Placement of a femoral catheter with the hydrolocalization technique
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Other Names:
  • Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Active Comparator: NS
Placement of a femoral neurostimulating catheter
Procedure: Placement of a femoral neurostimulating catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local anesthetic consumption
Time Frame: 36 hours postoperatively
36 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain scores with a VAS scale
Time Frame: 36 hours postoperatively
36 hours postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
incidence of side effects, consumption of iv analgesics
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
  • Principal Investigator: Mario Dauri, MD, Policlinico Tor Vergata

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

August 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLOCSTIM2

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.

Clinical Trials on Postoperative Pain

Clinical Trials on Placement of a femoral catheter with the hydrolocalization technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe