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
  Purpose

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.


Condition Intervention Phase
Foot Surgery
Procedure: Placement of perineural catheters with Hydrolocalization technique using
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

Resource links provided by NLM:


Further study details as provided by Attikon Hospital:

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

Secondary Outcome Measures:
  • pain scores [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546077

Contacts
Contact: Tatiana F Sidiropoulou, MD, PhD 00302105832371 tatianasid@gmail.com

Locations
Greece
Attikon Hospital Recruiting
Athens, Greece
Principal Investigator: Tatiana F Sidiropoulou, MD, PhD         
Principal Investigator: Theodosios Saranteas, MD, PhD         
Italy
Policlinico Tor Vergata Recruiting
Rome, Italy
Contact: Mario Dauri, MD       mario.dauri@ptvonline.it   
Principal Investigator: Mario Dauri, MD         
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Sidiropoulou Tatiana, Lecturer in Anesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01546077     History of Changes
Other Study ID Numbers: HLOCSTIM1
Study First Received: February 3, 2012
Last Updated: November 9, 2012
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

ClinicalTrials.gov processed this record on April 17, 2014