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

NCT06446960 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-22

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Lidocaine 20mg/ml

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

DRUG

Levobupivacaine Hydrochloride 1.25 MG/ML

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

DRUG

Sodium Chloride 0.9% Inj

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

Sponsors & Collaborators

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

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-09
Primary Completion
2026-09-08
Completion
2026-09-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446960 on ClinicalTrials.gov