Placement of Perineural Catheters in the Popliteal Region

NCT ID: NCT01546077

Last Updated: 2012-11-12

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Foot Surgery

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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Hydrolocalization technique group

Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound

Group Type ACTIVE_COMPARATOR

Placement of perineural catheters with Hydrolocalization technique using

Intervention Type PROCEDURE

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

Stimulating Catheter technique group

A technique for placement of popliteal catheter with the aid of a neurostimulator

Group Type ACTIVE_COMPARATOR

Placement of perineural catheters with Hydrolocalization technique using

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

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

Georgia G Kostopanagiotou, MD, PhD

Role: STUDY_CHAIR

Attikon Hospital

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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HLOCSTIM1

Identifier Type: -

Identifier Source: org_study_id