Popliteal Sciatic Nerve Block: Intraneural or Extraneural?

NCT ID: NCT01987128

Last Updated: 2015-02-27

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.

Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intraneural injection

All patients in the arm will receive a single intraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, in the sciatic nerve under echographic guidance.

Group Type EXPERIMENTAL

Intraneural injection

Intervention Type PROCEDURE

BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.

Ropivacaine

Intervention Type DRUG

PAJUNK SonoPlex 22G needle.

Intervention Type DEVICE

extraneural injection

All patients in the arm will receive a single extraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, around the sciatic nerve under echographic guidance.

Group Type ACTIVE_COMPARATOR

Extraneural injection

Intervention Type PROCEDURE

BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.

Ropivacaine

Intervention Type DRUG

PAJUNK SonoPlex 22G needle.

Intervention Type DEVICE

Interventions

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Intraneural injection

BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.

Intervention Type PROCEDURE

Extraneural injection

BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.

Intervention Type PROCEDURE

Ropivacaine

Intervention Type DRUG

PAJUNK SonoPlex 22G needle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II

Exclusion Criteria

* Neurological diseases
* Diabetes
* Allergies to used drugs
* Chronic pain in treatment
* Electrophysiological alterations at time zero analysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Gaetano Pini-CTO

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Cappelleri

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Cappelleri, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Gaetano Pini-CTO

Locations

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Istituto Ortopedico G. Pini

Milan, Milano, Italy

Site Status

Countries

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Italy

References

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Cappelleri G, Cedrati VL, Fedele LL, Gemma M, Camici L, Loiero M, Gallazzi MB, Cornaggia G. Effects of the Intraneural and Subparaneural Ultrasound-Guided Popliteal Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Clinical and Electrophysiological Comparison. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):430-7. doi: 10.1097/AAP.0000000000000413.

Reference Type DERIVED
PMID: 27281720 (View on PubMed)

Other Identifiers

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IOGPGC04-13

Identifier Type: -

Identifier Source: org_study_id