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Placement of Perineural Catheters in the Popliteal Region

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ClinicalTrials.gov Identifier: NCT01546077
Recruitment Status : Unknown
Verified November 2012 by Sidiropoulou Tatiana, Attikon Hospital.
Recruitment status was:  Recruiting
First Posted : March 7, 2012
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
Sidiropoulou Tatiana, Attikon Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : March 2013

Arm Intervention/treatment
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



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

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


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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

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

Publications:
Responsible Party: Sidiropoulou Tatiana, Lecturer in Anesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01546077     History of Changes
Other Study ID Numbers: HLOCSTIM1
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012