Placement of Perineural Catheters in the Popliteal Region

This study is currently recruiting participants. (see Contacts and Locations)
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

February 3, 2012
November 9, 2012
January 2012
March 2013   (final data collection date for primary outcome measure)
consumption of local anesthetics [ Time Frame: 36 hours PO ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01546077 on ClinicalTrials.gov Archive Site
pain scores [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Placement of Perineural Catheters in the Popliteal Region
Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Foot Surgery
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: 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
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. doi: 10.1093/bja/aer375.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tatiana F Sidiropoulou, MD, PhD 00302105832371 tatianasid@gmail.com
Greece,   Italy
 
NCT01546077
HLOCSTIM1
Not Provided
Sidiropoulou Tatiana, Attikon Hospital
Attikon Hospital
Not Provided
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
Attikon Hospital
November 2012

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