Comparison of Two Techniques for Placement of Perineural Femoral Catheters.

NCT ID: NCT01726192

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Postoperative Pain Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HLOC

Placement of a femoral catheter with the hydrolocalization technique

Group Type ACTIVE_COMPARATOR

Placement of a femoral catheter with the hydrolocalization technique

Intervention Type PROCEDURE

Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%

NS

Placement of a femoral neurostimulating catheter

Group Type ACTIVE_COMPARATOR

Placement of a femoral neurostimulating catheter

Intervention Type PROCEDURE

Interventions

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Placement of a femoral catheter with the hydrolocalization technique

Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%

Intervention Type PROCEDURE

Placement of a femoral neurostimulating catheter

Intervention Type PROCEDURE

Other Intervention Names

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Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sidiropoulou Tatiana

Lecturer in Anesthesiology, University of Athens

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatiana F Sidiropoulou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Theodosios Saranteas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Mario Dauri, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Tor Vergata

Locations

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Attikon Hospital

Athens, , Greece

Site Status RECRUITING

Policlinico Tor Vergata

Rome, , Italy

Site Status RECRUITING

Countries

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Greece Italy

Central Contacts

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Tatiana F Sidiropoulou, MD, PhD

Role: CONTACT

Phone: 00302105832371

Email: [email protected]

Facility Contacts

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Mario Dauri, MD

Role: primary

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 22088876 (View on PubMed)

Other Identifiers

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HLOCSTIM2

Identifier Type: -

Identifier Source: org_study_id