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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