Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Pain assessment using Numerical Pain Scale (END)
研究概览
简要总结
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.
详细描述
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 proposed to patients with chronic neuropathic pain of post-mastectomy syndrome that is not adequately managed by systemic treatment alone.
After consent, an inclusion assessment will be carried out including clinical examination, anamnesis, pain assessment (questionnaires PCS, NPS, DN4, NPSI and collect of antalgic treatment) and evaluation of quality of life (questionnaire SF12) and depression (questionnaire HADS).
Patients will then be randomly assigned to one of three treatment groups : Capsaicin, Botox-A, SPB (41 patients per group). The randomization will be balanced 1:1:1, controlled by minimisation (with a random factor set at 0.8) for the distribution of the following factors:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
N/A (since the study is open label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years;
- •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;
- •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;
- •Patient affiliated with a health insurance plan;
- •Patient informed and having consented to participate in the trial.
排除标准
- •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;
- •Breast reconstruction using flap or lipomodelling;
- •Indication for breast reconstruction within the next 8 weeks;
- •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;
- •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;
- •Infection or inflammation at the injection site;
- •Therapeutic/effective anticoagulation;
- •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;
- •Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome);
- •Heart rate lower than 60/minute;
- •Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block;
- •State of depression (HADS score ≥ 11);
- •Other contraindication to any of the study treatments;
- •Inability for the patient to follow the study schedule;
- •Inability for the patient or the healthcare team to perform the treatment within 2 weeks;
- •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 ;
- •Patient under guardianship or curatorship.
研究组 & 干预措施
Capsaicin 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.
干预措施: Capsaicin 8% Patch (Drug)
Botulinum 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.
干预措施: Botulinum Toxin A (Procedure)
Serratus 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 needed. This intervention aims to provide extended pain relief for neuropathic pain in post-mastectomy patients
干预措施: Serratus Plane Block (Procedure)
结局指标
主要结局
Pain assessment using Numerical Pain Scale (END)
时间窗: 8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.
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.
次要结局
- Success of Pain Control(Assessed at 8 weeks post-treatment.)
- Evolution of Pain Scores(Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.)
- Neuropathic Component Evaluation(Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.)
- Early Treatment Failure(Assessed at 7 and 14 days post-treatment)
- Modification of introduction of New Analgesic Treatment(Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.)
- Adverse Events(From study treatment to 24-weeks follow-up)
- HADS Scale Evaluation(Assessed at baseline, 8 weeks, and 24 weeks.)
- Quality of Life Assessment(Assessed at baseline, 8 weeks, and 24 weeks.)
- Patient General Impression of Change (PGIC)(Assessed at 8 weeks and 24 weeks)