RecruitingPhase 3NCT06446960

The Role of Peripheral Afferents in Modulating Post-stroke Central Pain


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

36 participants

Start Date

Feb 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood. Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD. The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Levobupivacaine Hydrochloride 1.25 MG/ML, a drug called Lidocaine 20mg/ml, and others for people with stroke. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLidocaine 20mg/ml

2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml

DRUGLevobupivacaine Hydrochloride 1.25 MG/ML

2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml

DRUGSodium Chloride 0.9% Inj

2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml


Locations(2)

CHU Ambroise Paré

Boulogne-Billancourt, France

Hôpital Raymond Poincaré

Garches, France

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NCT06446960


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