Comparison of Two Techniques for Placement of Perineural Femoral Catheters. (HLOCSTIM2)

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:
NCT01726192
First received: November 9, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.


Condition Intervention
Postoperative Pain
Anterior Cruciate Ligament Reconstruction
Procedure: Placement of a femoral catheter with the hydrolocalization technique
Procedure: Placement of a femoral neurostimulating catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.

Further study details as provided by Attikon Hospital:

Primary Outcome Measures:
  • local anesthetic consumption [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores with a VAS scale [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • incidence of side effects, consumption of iv analgesics [ Time Frame: 36 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HLOC
Placement of a femoral catheter with the hydrolocalization technique
Procedure: Placement of a femoral catheter with the hydrolocalization technique
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Other Name: Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Active Comparator: NS
Placement of a femoral neurostimulating catheter
Procedure: Placement of a femoral neurostimulating catheter

Detailed Description:

The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.

Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726192

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
Principal Investigator: Mario Dauri, MD Policlinico Tor Vergata
  More Information

Publications:
Responsible Party: Sidiropoulou Tatiana, Lecturer in Anesthesiology, University of Athens, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01726192     History of Changes
Other Study ID Numbers: HLOCSTIM2
Study First Received: November 9, 2012
Last Updated: November 13, 2012
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014