Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 17, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06807164). This is a study registration, not published results. Lead sponsor: Centre Oscar Lambret. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 123 participants (ESTIMATED). Conditions: Post-Mastectomy Neuropathic Pain Syndrome. Interventions: DRUG: Capsaicin 8% Patch; PROCEDURE: Serratus Plane Block; PROCEDURE: Botulinum Toxin A. Primary outcome measures: Pain assessment using Numerical Pain Scale (END) , 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.. Brief summary: 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.