Placement of Perineural Catheters in the Popliteal Region

This study is currently recruiting participants.

Verified November 2012 by Attikon Hospital

Sponsor:

Information provided by (Responsible Party):

Sidiropoulou Tatiana, Attikon Hospital

ClinicalTrials.gov Identifier:

NCT01546077

First received: February 3, 2012

Last updated: November 9, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2012

Last Updated Date

November 9, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

consumption of local anesthetics [ Time Frame: 36 hours PO ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01546077 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pain scores [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Placement of Perineural Catheters in the Popliteal Region

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Foot Surgery

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Hydrolocalization technique group
Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound

Intervention: Procedure: Placement of perineural catheters with Hydrolocalization technique using
Active Comparator: Stimulating Catheter technique group
A technique for placement of popliteal catheter with the aid of a neurostimulator

Intervention: Procedure: Placement of perineural catheters with Hydrolocalization technique using

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tatiana F Sidiropoulou, MD, PhD

00302105832371

tatianasid@gmail.com

Location Countries ^ICMJE

Greece, Italy

Administrative Information

NCT Number ^ICMJE

NCT01546077

Other Study ID Numbers ^ICMJE

HLOCSTIM1

Has Data Monitoring Committee

Not Provided

Responsible Party

Sidiropoulou Tatiana, Attikon Hospital

Study Sponsor ^ICMJE

Attikon Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Attikon Hospital

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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