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Placement of Perineural Catheters in the Popliteal Region

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Sidiropoulou Tatiana, Attikon Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546077
First Posted: March 7, 2012
Last Update Posted: November 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidiropoulou Tatiana, Attikon Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

Further study details as provided by Sidiropoulou Tatiana, Attikon Hospital:

Primary Outcome Measures:
  • consumption of local anesthetics [ Time Frame: 36 hours PO ]

Secondary Outcome Measures:
  • pain scores [ Time Frame: 36 hours postoperatively ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 3, 2012
First Posted: March 7, 2012
Last Update Posted: November 12, 2012
Last Verified: November 2012