beta
Trial Radar AI
Clinical Trial NCT06807164 (SerCaBot) for Post-Mastectomy Neuropathic Pain Syndrome is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (SerCaBot) Phase 2 123 Remote

Recruiting
Clinical Trial NCT06807164 (SerCaBot) is designed to study Treatment for Post-Mastectomy Neuropathic Pain Syndrome. It is a Phase 2 interventional study that is recruiting, having started on 31 March 2026, with plans to enroll 123 participants. Led by Centre Oscar Lambret, it is expected to complete by 30 December 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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...

Show More
Detailed Description
SerCaBot is a randomized, open-label, phase II clinical trial designed to evaluate the efficacy of a treatment with Serratus Plane Block (SPB) or Botox-A compared to capsaicin for the control of chronic neuropathic pain of post-mastectomy syndrom, that is not adequately managed by systemic treatment alone.

123 patients with will be recruited over 24 months at the Centre Oscar Lambret.

This clinical trial will be pr...

Show More
Official Title

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

Conditions
Post-Mastectomy Neuropathic Pain Syndrome
Other Study IDs
  • SerCaBot
  • SerCaBot-2302
  • 2024-517420-20-00 (EU Study (CTIS) Number)
NCT ID Number
NCT06807164
Start Date (Actual)
2026-03-31
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-12-30
Enrollment (Estimated)
123
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Breast cancer
Chronic neuropathic pain
Post-mastectomy pain
Serratus Plane Block (SPB)
Capsaicin
Pain management
Botulinum toxin type A
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorCapsaicin 8% Patch (Control)
Participants in this arm will receive an 8% capsaicin patch in a single treatment session in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persists, the capsaicin patch application may be repeated at 12 weeks.
Capsaicin 8% Patch
One or two capsaicin patch (8%) are applied for 60 minutes to the site of neuropathic pain, in day-hospital. An oral, antalgic pre-medication may be done with one of the following medications (alone or association): paracetamol 1g, nefopam 30 mg, tramadol 100 mg, morphine 10mg, oxycodone 5mg. Capsaicin will be administered in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain persist...Show More
ExperimentalSerratus Plane Block (SPB)
Participants in this arm will undergo a Serratus Plane Block (SPB), a local anesthetic injection administered by a trained anesthesiologist, in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB can be repeated every two weeks up to a maximum of four sessions within the initial 8-week period if pain persists. A repeat treatment may be considered at 12 weeks if further pain control is...Show More
Serratus Plane Block
The Serratus Plane Block (SPB) is a nerve block performed by a trained anesthesiologist to provide localized pain relief. It involves the injection of a local anesthetic: Maximum 150 mg naropeine combined with 150 μg clonidine hydrochloride into the serratus anterior plane under ultrasound guidance. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation.The SBP will...Show More
ExperimentalBotulinum Toxin A (Botox-A) Injection
This arm involves administration of Botulinum Toxin A (Botox-A) at the site of pain, in addition to a systemic treatment that has been ongoing for at least 4 weeks. If pain remains unresolved, the injection may be repeated at 12 weeks. Botox-A is used here as a local, long-lasting analgesic intervention aimed at reducing chronic neuropathic pain in patients post-mastectomy.
Botulinum Toxin A
Botulinum Toxin A (Botox-A) is injected into the affected area, with a total of 300 units administered across up to 60 injection sites. An anesthesiologist will perform the procedure in a post-interventional recovery room, with light sedation. This intervention will be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks, and is aimed at providing prolonged pain relief for post-m...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pain assessment using Numerical Pain Scale (END)
The primary outcome measure is pain assessed by self-evaluation using the Numerical Pain Scale (END) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest, evaluated 8 weeks after treatment (or 9 weeks after randomization if treatment was not performed). The patient's self-assessment reflects individual treatment efficacy. In case of treatment interruption due to immediate intolerance or technical issues, the baseline END will be considered for the primary analysis.
8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Success of Pain Control
Defined as a reduction in pain of 3 points or more on the Numerical Pain Scale (END) at 8 weeks, with failure indicated in other cases.
Assessed at 8 weeks post-treatment.
Evolution of Pain Scores
Change in pain levels as self-reported by the patient using the END at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated at 12 weeks).
Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Neuropathic Component Evaluation
Change in neuropathic symptoms assessed via the Neuropathic Pain Symptom Inventory (NPSI) at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated at 12 weeks).
Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Early Treatment Failure
Early failure of local analgesic treatment defined by failure to perform the procedure (due to intolerance or technical issues) or failure to control pain as evaluated at 7 and 14 days post-procedure.
Assessed at 7 and 14 days post-treatment
Modification of introduction of New Analgesic Treatment
Documentation of any change in systemic treatement or introduction of new analgesic treatments (e.g., antiepileptics, antidepressants, opioids), with dosages collected at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks if treatment is repeated).
Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
Adverse Events
Monitoring of adverse events possibly related to the treatment (capsaicin, botulinum toxin type A, or SBP block) during and after the local procedure, graded according to NCI-CTCAE v5.0.
From study treatment to 24-weeks follow-up
HADS Scale Evaluation
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) at baseline, 8 weeks, and 24 weeks.
Assessed at baseline, 8 weeks, and 24 weeks.
Quality of Life Assessment
Evaluation of health-related quality of life using the SF12 scale at baseline, 8 weeks, and 24 weeks.
Assessed at baseline, 8 weeks, and 24 weeks.
Patient General Impression of Change (PGIC)
Self-assessment of change in condition from 1 (no change or worse) to 7 (considerable improvement) measured at 8 weeks and 24 weeks.
Assessed at 8 weeks and 24 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  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.

  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.

Centre Oscar Lambret logoCentre Oscar Lambret
  • 🏛️...
Show More
Study Central Contact
Contact: Julien THERY, Project manager, +33 (0)3 20 29 59 18, [email protected]
Contact: Victor DESTEIRDT, Clinical Research Associate-M, +33 (0)3 20 29 59 18, [email protected]
1 Study Locations in 1 Countries

Hauts-de-France

Centre Oscar Lambret, Lille, Hauts-de-France, 59000, France
Solaya CHALAL, Contact, +33 03 20 29 56 38, [email protected]
Odycée FOURNIER, Contact, +33 03 20 29 57 69, [email protected]
Didier DELBROUCK, Dr, Principal Investigator
Adrien LEMOINE, Dr, Sub-Investigator
Recruiting