Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy

NCT ID: NCT02384915

Last Updated: 2015-05-08

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

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The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

Detailed Description

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Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.

Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Conditions

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Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Spinal anesthesia

Intrathecal injection of 2 ml (40 mg) of 2% hyperbaric prilocaine at L3-L4 interspaces through a 100mm Sprotte 25 G spinal needle (Pencan, b-brawn, Germay) in lateral decubitus position, (with limb to operate declive).

Group Type EXPERIMENTAL

prilocaine

Intervention Type DRUG

Spinal anesthesia

Intervention Type PROCEDURE

intrathecal injection of 40 mg hyperbaric prilocaine

peripheral nerve block

Ultrasound-guided sciatic-femoral nerve block injecting 25 ml of a 2% mepivacaine solution,15 ml on femoral nerve and 10 ml on sciatic nerve through a 80 mm 22g eco-reflex needle (Sonoplex, Pajunk, Germany)

Group Type ACTIVE_COMPARATOR

mepivacaine

Intervention Type DRUG

Sciatic-femoral Nerve Block

Intervention Type PROCEDURE

ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve

Sonoplex, Pajunk

Intervention Type DEVICE

Interventions

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prilocaine

Intervention Type DRUG

mepivacaine

Intervention Type DRUG

Sciatic-femoral Nerve Block

ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve

Intervention Type PROCEDURE

Spinal anesthesia

intrathecal injection of 40 mg hyperbaric prilocaine

Intervention Type PROCEDURE

Sonoplex, Pajunk

Intervention Type DEVICE

Other Intervention Names

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prilotekal carbocaine

Eligibility Criteria

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Inclusion Criteria

* outpatients knee arthroscopy

Exclusion Criteria

* diabetes
* allergy to local anesthetic
* patient refusal
* chronic opiods assumption
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

Locations

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Istituto Ortopedico G. Pini

Milan, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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IOGPGC07

Identifier Type: -

Identifier Source: org_study_id

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