Actively Recruiting
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-04-22
36
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older with no maximum age limit
- Pain in the upper or lower limb that can be fully covered by a peripheral nerve block
- Chronic pain lasting at least 6 months
- Ischemic or hemorrhagic stroke at least 6 months ago confirmed by clinical assessment and MRI
- Post-stroke central neuropathic pain meeting NeuPSIG criteria with a DN4 score of at least 4 out of 10
- Spontaneous pain intensity of 4 or higher on an 11-point scale at inclusion and before each block
- Affiliated with a social security scheme or beneficiary of such a scheme
- Stable oral analgesic treatment for at least 2 weeks before inclusion
- Signed informed consent
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Under legal protection (safeguard of justice, curatorship, guardianship)
- Ongoing psychiatric illness (major depression, psychosis) or cognitive disorders preventing understanding of protocol and questionnaires
- Pain too widespread in one limb or hemicycle to be covered by blocks
- Current drug or substance abuse
- Language or comprehension disorders, or illiteracy
- Moderate to severe kidney or liver impairment
- Contraindications to local anesthetics for perineural blocks (infection, inflammation, allergy)
- Pregnancy or breastfeeding
- Known allergy to lidocaine, levobupivacaine, amide-type local anesthetics, or excipients used
- Recurrent porphyria or severe low blood pressure contraindicating treatment
- Current treatment with certain antiarrhythmic drugs causing torsades de pointes or with local anesthetic activity that cannot be stopped
- Pain intensity below 4 out of 10 at the time of blocks
- Need to change analgesic treatment at the start or during the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU Ambroise Paré
Boulogne-Billancourt, France, 92100
Actively Recruiting
2
Hôpital Raymond Poincaré
Garches, France, 92380
Actively Recruiting
Research Team
V
VALERIA MARTINEZ, MD
CONTACT
N
NADINE ATTAL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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