Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait

NCT ID: NCT05519592

Last Updated: 2022-08-29

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2023-10-30

Brief Summary

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To assess feasability, tolerance of anesthesic intramuscular motor block. To study immediate effects on differents muscles : gluteus maximus, rectus femoris in a hemiparetic population (over 15 days) To precise the role of the muscles which could be rehabilitatoin targets.

Detailed Description

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Spastic paresis comprises both muscular and neurological disorders affecting movement through mostly the antagonist muscles compared to the agonist : muscular : spastic myopathy, shortening, stretch-sensitive paresis and neurogenic : spastic dystonia and cocontraction.

About gait, most of the litterature focuses on distal muscles targets. There are no studies about proxmial muscles role (gluteus maximus). Anesthesic perineural block have the disavantage to induce sensitive block as intramuscular block do not.

Conditions

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Neurologic Disorder Spastic Hemiplegia Gait, Hemiplegic Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ropivacaine

Ropivacaine intramuscular injection

Group Type EXPERIMENTAL

Ropivacaine injection

Intervention Type DRUG

Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)

Control

Sodium Chlorure intramuscular injection

Group Type PLACEBO_COMPARATOR

Sodium Chloride Injection

Intervention Type DRUG

Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

Interventions

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Ropivacaine injection

Intramuscular ropivacaine injection (gluteus maximus and rectus femoris)

Intervention Type DRUG

Sodium Chloride Injection

Intramuscular sodium chloride injection (gluteus maximus and rectus femoris)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* able to consent
* avoiding ground swing phase gait disorder

Exclusion Criteria

* severe cognitive disorder
* INR \> 3.5
* local cutaneous affection on injection sites
* acute medical affection
* seizure
* hypersensitivity to anesthesics
* brugada syndrome
* porphyria
* severe cardiac disorder
* polyradiculopathy
* botulinum toxin injection \< 2 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ETIENNE SAVARD

Hospital Practictioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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etienne savard

Role: CONTACT

0033149813299

Other Identifiers

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2022-A01457-36

Identifier Type: -

Identifier Source: org_study_id

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