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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
  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:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

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 May 16, 2013