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

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:
NCT01726192
First Posted: November 14, 2012
Last Update Posted: November 14, 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 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
Intervention Model: Parallel Assignment
Masking: Single (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 Sidiropoulou Tatiana, Attikon Hospital:

Primary Outcome Measures:
  • local anesthetic consumption [ Time Frame: 36 hours postoperatively ]

Secondary Outcome Measures:
  • Pain scores with a VAS scale [ Time Frame: 36 hours postoperatively ]

Other Outcome Measures:
  • incidence of side effects, consumption of iv analgesics [ Time Frame: 36 hours postoperatively ]

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

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): 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
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents


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