Serratus Plane Block (SPB) Versus Capsacine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
Status:
RECRUITING
Trial end date:
2027-12-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Centre Oscar Lambret
Collaborators:
CTD-CNO, Caen Ligue contre le cancer, France Santelys Association
Treatments:
Botulinum Toxins, Type A Capsaicin Transdermal Patch