Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait (ProxiBlock)

Henri Mondor University Hospital

Status: Not yet enrolling

Conditions: Block; Gait, Hemiplegic; Neurologic Disorder; Spastic Hemiplegia

Treatments: Drug: Ropivacaine injection; Drug: Sodium Chloride Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05519592

2022-A01457-36

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

Ropivacaine intramuscular injection

Treatment:

Drug: Ropivacaine injection

Control

Placebo Comparator group

Description:

Sodium Chlorure intramuscular injection

Treatment:

Drug: Sodium Chloride Injection