Evaluating nerve blocks for post-stroke pain relief

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

This study is testing if two different nerve block treatments can help people with chronic pain after a stroke feel better compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 2 sites (Boulogne-Billancourt and 1 other locations)
• Trial ID: NCT06446960 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of two types of peripheral nerve blocks in alleviating central post-stroke pain, which is often resistant to standard pain medications. Patients will be randomly assigned to receive either lidocaine, levobupivacaine, or a placebo, with treatments administered 14 days apart. Pain intensity will be measured before and after each block, as well as through patient diaries over the following weeks. The study will involve two medical centers in France and will focus on patients suffering from chronic neuropathic pain following a stroke.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke at least six months prior and suffer from chronic neuropathic pain.

Not a fit: Patients with acute pain or those who have not experienced a stroke for at least six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from debilitating post-stroke pain.

How similar studies have performed: While the role of peripheral nerves in post-stroke pain is a relatively novel area of investigation, previous studies have suggested potential benefits from similar approaches.

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
2. Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
3. Chronic pain for at least 6 months
4. Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
5. Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic pain according to the NeuPSIG algorithm and with a DN4 screening questionnaire score of at least 4 out of 10.
6. Spontaneous pain intensity greater than or equal to 4 out of 10 on an 11-point numerical scale (EN) at inclusion and randomisation (i.e. just before each block)
7. Patients affiliated to a social security scheme or beneficiaries of such a scheme
8. Stable oral analgesic pharmacological treatment for at least 2 weeks prior to inclusion
9. Acceptance and signing of the informed consent

Exclusion Criteria:

1. Inability or unwillingness to sign an informed consent
2. Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
3. Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol and questionnaires
4. Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
5. Ongoing drug or substance abuse
6. Language (aphasia) or comprehension disorders, illiteracy
7. Moderate to severe renal or hepatic impairment
8. Contraindication to local anaesthetics for use in perineural blocks (infection or acute inflammation in the injection area, known allergy).
9. Pregnancy or breastfeeding
10. Known hypersensitivity to lidocaine, levobupivacaine, amide-linked local anaesthetics or to any of the excipients contained in the specialities used in the study.
11. Patients with recurrent porphyria or severe hypotension contraindicating treatment with lidocaine and/or levobupivacaine
12. Current treatment with antiarrhythmic drugs causing torsades de pointes (amiodarone, disopyramide, quinidinics, sotalol...) or with antiarrhythmic drugs with local anaesthetic activity (mexiletine or class III antiarrhythmic drugs) and cannot be discontinued.
13. Too little pain at the time of the blocks (\< 4 out of 10)
14. Need to modify analgesic pharmacological treatment at the beginning or during the study

Where this trial is running

Boulogne-Billancourt and 1 other locations

• CHU Ambroise Paré — Boulogne-Billancourt, France (Recruiting)
• Hôpital Raymond Poincaré — Garches, France (Recruiting)

Study contacts

• Study coordinator: Valeria Martinez, Md

Conditions Stroke; Ischemic Stroke; Central Neuropathic Pain