Ropivacaine hydrochloride for Postmastectomy pain syndrome|Chronic neuropathic pain

Inclusion criteria

• {"criterion_text":"- Women aged ≥ 18 years old\n- Unilateral breast cancer treated with total or partial mastectomy: - using sentinel lymph node technique (SLN) or axillary dissection; - with or without immediate breast reconstruction using a prosthesis; - associated or not with radiotherapy and/or chemotherapy;\n- Patient presenting with at least moderate chronic neuropathic pain, defined by: NRS (Numerical Rating Scale) ≥ 3 and DN4 ≥ 4, Pain confined to a well-localized area (≤ 240 cm²) at the surgical site, in the axillary hollow, or on the inner side of the ipsilateral arm, Occurring between 3 and 9 months post-breast surgery, With indication for add-on locoregional therapy to a systemic treatment for chronic neuropathic pain, as recommended by the SFETD (French Society for the Study and Treatment of Pain)— tricyclic antidepressants, SNRIs, or a gabapentinoid at an appropriate dosage, plus a lidocaine patch—which has been in place and stable for at least 4 weeks.\n- Patient affiliated with a health insurance plan\n- Patient informed and consenting to participate in the trial"}

Exclusion criteria

• {"criterion_text":"- Ipsilateral breast cancer recurrence, regardless of the first treatment\n- Inability for the patient to follow the study schedule\n- History of breast or thoracic surgery prior to mastectomy with residual pain\n- Painful polyneuropathy related to chemotherapy requiring treatment\n- Ongoing or planned loco-regional adjuvant radiotherapy within the next 8 weeks\n- Treatment area unsuitable for potential treatment with botulinum toxin type A\n- Breast reconstruction using flap or lipofilling\n- Indication for breast reconstruction within the next 8 weeks\n- Chronic pain of other etiology such as: - Neuropathic pain secondary to a neuroma (localized pain), - Radiodermatitis, - Phantom breast pain, - Lymphedema, - Complex regional pain syndrome, - Adhesive capsulitis, - Fibromyalgia\n- Hypersensitivity or allergy to anesthetics, capsaicin, naropaine, clonidine hydrochloride, amide-type local anesthetics, botulinum toxin type A, or any excipient contained in the preparations\n- Inability for the patient or the healthcare team to administer the treatment within 2 weeks\n- Infection or inflammation at the injection site\n- Pregnant or breastfeeding women, women of childbearing potential not using a highly effective method of contraception during the trial and for at least 1 month after the end of treatment\n- Patients under guardianship or curatorship\n- Curative/effective anticoagulation\n- Clinical signs or medical history leading to the diagnosis of: - Hemostatic disorders, - Local infection, - Severe renal insufficiency (creatinine clearance < 30 mL/min), - Thrombocytopenia < 50,000 platelets/mm³\n- Generalized muscle activity disorders (e.g., myasthenia, Lambert-Eaton syndrome)\n- Heart rate lower than 60/minute\n- Severe bradyarrhythmia due to sick sinus syndrome or second or third-degree atrioventricular block\n- State of depression (HADS score ≥ 11)\n- Other contraindication to any of the study treatments"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint assesses pain through self-assessment using the Numerical Pain Scale (NPS), rated from 0 to 10, at 8 weeks after treatment or 9 weeks after randomization. If treatment fails before 8 weeks, assessment may occur earlier. Self-assessment is preferred as it reflects the individual's perception of treatment efficacy. If local treatment is interrupted, the baseline NPS measurement will be used for the primary analysis.","definition_or_measurement_approach":"Pain measured by patient self-assessment on the Numerical Pain Scale (NPS) 0-10 at 8 weeks after treatment (or 9 weeks after randomization); earlier assessment allowed if treatment fails; if local treatment interrupted baseline NPS used in primary analysis."}

Secondary endpoints

• {"endpoint_text":"- Success in pain control at 8 weeks defined by a reduction in pain of 3 points or more, versus failure in other cases","definition_or_measurement_approach":"Binary success defined as NPS reduction ≥ 3 points at 8 weeks."}
• {"endpoint_text":"- Evolution of the NPS after treatment, self-assessed by the patient according to the same modalities as for the primary endpoint, at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks in case of treatment repetition at 12 weeks); data collection is planned during pain management consultations and between these consultations through remote evaluations","definition_or_measurement_approach":"Repeated patient self-assessed NPS measurements at specified timepoints (1,2,4,6,8,24 weeks and additional timepoints if treatment repeated). Data collected in clinic and via remote evaluations."}
• {"endpoint_text":"- Evolution of the neuropathic component, self-assessed via the NPSI questionnaire, at 1, 2, 4, 6, 8, and 24 weeks after treatment (and at 13, 14, 16, and 18 weeks in case of treatment repetition at 12 weeks)","definition_or_measurement_approach":"Neuropathic component assessed by the Neuropathic Pain Symptom Inventory (NPSI) at specified timepoints."}
• {"endpoint_text":"- Early failure of local analgesic treatment, defined by: - Treatment failure: interruption of the procedure (due to intolerance in the Capsaicin and Botox-A groups, and due to technical problems in the SPB group); - Failure in pain control assessed 7 and 14 days after the procedure (or earlier in case of a call, minimum 72 hours), defined by no improvement in the NPS leading to the need to introduce a new systemic antineuropathic treatment, or the need to resort to TENS","definition_or_measurement_approach":"Composite early-failure endpoint including procedural interruption and lack of NPS improvement at 7 and 14 days (or earlier if needed) leading to new systemic therapy or TENS."}
• {"endpoint_text":"- Modification or introduction of a new systemic analgesic treatment (gabapentinoid, tricyclic antidepressant, IRSNA, opioids) or TENS","definition_or_measurement_approach":"Record of change/introduction of systemic analgesic therapy or use of TENS as outcome."}
• {"endpoint_text":"- Adverse events possibly related to the treatment performed (capsaicin, botulinum toxin type A, or SPB block), during the local procedure and afterwards, graded according to the NCI-CTCAE v5.0 scale. Pain leading to cessation of the procedure as well as a hematoma or pneumothorax of grade 2 or more will be considered severe adverse events","definition_or_measurement_approach":"Safety assessed by recording adverse events graded per NCI-CTCAE v5.0; specific events (procedure-stopping pain, hematoma, pneumothorax grade ≥2) considered SAEs."}
• {"endpoint_text":"- HADS scale, measured at baseline and during visits at 8 and 24 weeks","definition_or_measurement_approach":"Hospital Anxiety and Depression Scale (HADS) at baseline, 8 and 24 weeks."}
• {"endpoint_text":"- Quality of Life scale (Health Related QOL: SF-12) measured at baseline and during visits at 8 and 24 weeks","definition_or_measurement_approach":"SF-12 health-related quality of life questionnaire at baseline, 8 and 24 weeks."}
• {"endpoint_text":"- Patient General Impression of Change (PGIC) self-assessment scale from 1 (no change or worse) to 7 (considerable improvement making a clear difference), measured during visits at 8 and 24 weeks","definition_or_measurement_approach":"PGIC self-assessment (1-7) at 8 and 24 weeks."}

France

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

165

Number Of Sites

1

Number Of Participants

123

Primary sponsor

Full Name

Centre Oscar Lambret

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Ligue Nationale Contre le Cancer","duties_or_roles":"Source of monetary support","organisation_type":""}