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RECRUITING
NCT06446960
PHASE3

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

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

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-02-12

Completion Date

2027-02-12

Last Updated

2025-03-12

Healthy Volunteers

No

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

Locations (2)

CHU Ambroise Paré

Boulogne-Billancourt, France

Hôpital Raymond Poincaré

Garches, France