Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
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.
• Women aged ≥ 18 years;
• Unilateral breast cancer treated by total or partial mastectomy:
‣ with sentinel lymph node technique (SLN) or axillary dissection;
⁃ with or without immediate reconstruction using a prosthesis;
⁃ associated or not with radiotherapy and/or chemotherapy;
• Presenting moderate to severe chronic neuropathic pain, defined by:
‣ Numerical Pain Scale (NPS) ≥ 3 and DN4 ≥ 4,
⁃ on a localised aera ((≤ 240 cm²), at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm,
⁃ between 3 and 9 months after breast surgery,
⁃ with indication of additional locoregional treatment in complement to a 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;
• Patient affiliated with a health insurance plan;
• Patient informed and having consented to participate in the trial.