drugset / Trial / NCT06446960

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

NCT06446960

RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Levobupivacaine Other / unclassified 20 ml Other
Subject Lidocaine Other / unclassified 20 ml Other

Indications