OncoMatch/Clinical Trials/NCT06807164
Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
Is NCT06807164 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capsaicin 8% Patch for post-mastectomy neuropathic pain syndrome.
Treatment: Capsaicin 8% Patch — The goal of this phase II clinical trial is to study the effectiveness of a treatment with Serratus Plane Block (SPB) or Botox-A in comparison with capsaicin for the control of chronic neuropathic pain of post-mastectomy syndrom, that is not adequately managed by systemic treatment alone. The primary outcome will be the pain evaluation at 8 weeks. 123 patients with chronic neuropathic pain of post-mastectomy syndrom insufficiently relieved by systemic treatment alone will be recruited over 24 months at the Centre Oscar Lambret. Patients will be randomly assigned to one of three treatment groups (41 patients per group): Capsaicin Botulinum toxin A SPB Patients will be followed for 24 weeks after the study treatment. The follow-up will include remote evaluation and 2 medical visits during which pain and quality of life will be assessed.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: systemic treatment of chronic neuropathic pain (tricyclic antidepressants, IRSNA, gabapentinoid, lidocaine patch) — chronic neuropathic pain
systemic treatment of chronic neuropathic pain, as recommended by the SFETD - French Society for the Study and Treatment of Pain (tricyclic antidepressants or IRSNA or gabapentinoid PLUS lidocaine patch, at the appropriate dosage) and implemented for at least 4 weeks
Lab requirements
Blood counts
Thrombocytopenia < 50,000 platelets/mm3 [excluded]
Kidney function
Severe renal insufficiency (creatinine clearance < 30 mL/min) [excluded]
Cardiac function
Heart rate lower than 60/minute; Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block [excluded]
Severe renal insufficiency (creatinine clearance < 30 mL/min); Thrombocytopenia < 50,000 platelets/mm3; Heart rate lower than 60/minute; Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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