RecruitingPhase 2NCT06807164

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

Sponsor

Centre Oscar Lambret

Enrollment

123 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Post-Mastectomy Neuropathic Pain Syndrome

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 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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three different treatments for chronic nerve pain (neuropathic pain) that develops after breast cancer surgery: a nerve-blocking injection (serratus plane block), a high-concentration capsaicin patch (derived from chili peppers), and botulinum toxin A (Botox) injections. **You may be eligible if...** - You are a woman aged 18 or older - You have had a total or partial mastectomy for breast cancer (with or without reconstruction) - You have moderate to severe nerve pain at the surgical site, armpit, or inner arm that has been present for 3 to 9 months after surgery - Your pain is confirmed as neuropathic (based on specific pain scores) - You have already been on appropriate pain medications for at least 4 weeks without full relief **You may NOT be eligible if...** - Your breast cancer has returned - You had a prior breast or chest surgery that left residual pain before your mastectomy - You have painful nerve damage from chemotherapy requiring its own treatment - You are still undergoing radiation to the area or have upcoming radiation within 8 weeks - Your reconstruction used tissue flaps or fat transfer - You have another cause of pain such as fibromyalgia, lymphedema, or phantom breast pain - You are allergic to any of the study treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapsaicin 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 persists, the capsaicin patch application may be repeated at 12 weeks.

PROCEDURESerratus 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 be carried out in addition to a systemic treatment that has been ongoing for at least 4 weeks. The SPB may be repeated every two weeks up to four times in the initial 8-week period, with an additional repeat at 12 weeks if pain control remains insufficient.

PROCEDUREBotulinum 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-mastectomy neuropathic pain. Light sedation is provided, and injections may be repeated at 12 weeks if necessary.

Locations(1)

Centre Oscar Lambret

Lille, Hauts-de-France, France

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NCT06807164