Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-… (NCT06807164) | Clinical Trial Compass
RecruitingPhase 2
Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
France123 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women aged ≥ 18 years;
✓. Unilateral breast cancer treated by total or partial mastectomy:
✓. Presenting moderate to severe chronic neuropathic pain, defined by:
✓. Patient affiliated with a health insurance plan;
✓. Patient informed and having consented to participate in the trial.
Exclusion criteria
✕. Ipsilateral breast cancer recurrence, regardless of the first treatment;
✕. History of breast or thoracic surgery prior to mastectomy with residual pain;
✕. Painful polyneuropathy related to chemotherapy requiring treatment;
✕. Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks;
✕. Treatment area not suitable for potential botulinum toxin type A treatment;
What they're measuring
1
Pain assessment using Numerical Pain Scale (END)
Timeframe: 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.