Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome

NCT ID
NCT06807164
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Centre Oscar Lambret
Conditions
Post-Mastectomy Neuropathic Pain Syndrome

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 123 participants (Estimated).

What is being studied

  • Intervention: Alkaloids
  • Intervention: Alkenes
  • Intervention: Amides
  • Intervention: Amino Acids, Peptides, and Proteins
  • Intervention: Bacterial Proteins
  • Intervention: Bacterial Toxins
  • Intervention: Benzene Derivatives
  • Intervention: Biological Factors
  • Procedure: Botulinum Toxin A
  • Intervention: Botulinum Toxins
  • Intervention: Botulinum Toxins, Type A
  • Intervention: Capsaicin
  • Drug: Capsaicin 8% Patch
  • Intervention: Catechols
  • Intervention: Endopeptidases
  • Intervention: Enzymes
  • Intervention: Enzymes and Coenzymes
  • Intervention: Equipment and Supplies
  • Intervention: Fatty Acids
  • Intervention: Fatty Acids, Monounsaturated
  • Intervention: Fatty Acids, Unsaturated
  • Intervention: Heterocyclic Compounds
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Acyclic
  • Intervention: Hydrocarbons, Aromatic
  • Intervention: Hydrocarbons, Cyclic
  • Intervention: Hydrolases
  • Intervention: Lipids
  • Intervention: Metalloendopeptidases
  • Intervention: Metalloproteases
  • Intervention: Organic Chemicals
  • Intervention: Peptide Hydrolases
  • Intervention: Phenols
  • Intervention: Polyunsaturated Alkamides
  • Intervention: Proteins
  • Procedure: Serratus Plane Block
  • Intervention: Solanaceous Alkaloids
  • Intervention: Toxins, Biological
  • Intervention: Transdermal Patch

Who may be eligible

Ages
18 Years to no maximum
Sex
Female
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria : 1. Women aged ≥ 18 years; 2. 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; 3. 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; 4. Patient affiliated with a health insurance plan; 5. Patient informed and having consented to participate in the trial. Exclusion Criteria : 1. Ipsilateral breast cancer recurrence, regardless of the first treatment; 2. History of breast or thoracic surgery prior to mastectomy with residual pain; 3. Painful polyneuropathy related to chemotherapy requiring treatment; 4. Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks; 5. Treatment area not suitable for potential botulinum toxin type A treatment; 6. Breast reconstruction using flap or lipomodelling; 7. Indication for breast reconstruction within the next 8 weeks; 8. Chronic pain of another etiology such as: * Neuropathic pain secondary to a neuroma (localized pain), * Radiodermatitis, * Phantom breast pain, * Lymphedema, * Complex regional pain syndrome, * Adhesive capsulitis, * Fibromyalgia; 9. Hypersensitivity or allergy to anesthetics, capsaicin, naropein, clonidine hydrochloride, an amide-type local anesthetic, botulinum toxin type A, or any excipient contained in the preparations; 10. Infection or inflammation at the injection site; 11. Therapeutic/effective anticoagulation; 12. Clinical signs or medical history leading to the diagnosis of: * Hemostasis disorder, * Local infection, * Severe renal insufficiency (creatinine clearance \< 30 mL/min), * Thrombocytopenia \< 50,000 platelets/mm3; 13. Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome); 14. Heart rate lower than 60/minute; 15. Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block; 16. State of depression (HADS score ≥ 11); 17. Other contraindication to any of the study treatments; 18. Inability for the patient to follow the study schedule; 19. Inability for the patient or the healthcare team to perform the treatment within 2 weeks; 20. Pregnant or breastfeeding women, women who are able to conceive and who do not use a highly effective method of contraception during the trial and for at least 1 month after the end of treatment ; 21. Patient under guardianship or curatorship.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: France

  • Hauts-de-France, France: 1

Sample of listed locations

  • Centre Oscar Lambret — Lille, Hauts-de-France, 59000, France — Recruiting

Study details

Start date
October 31, 2026
Primary completion date
August 30, 2027
Completion date
December 30, 2027
First posted
February 4, 2025
Collaborators
CTD-CNO, Caen, Ligue contre le cancer, France, Santelys Association

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06807164
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06807164 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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