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

ConditionPost-Mastectomy Neuropathic Pain Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Oscar Lambret

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥ 18 years;

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capsaicin 8% Patch

    Drug

    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.

  • Serratus Plane Block

    Procedure/Surgery

    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.

  • Botulinum Toxin A

    Procedure/Surgery

    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.

Treatment groups

123 Participants
are divided into 3 treatment groups
Group A: Capsaicin 8% Patch (Control)Active comparator 1 intervention
Group B: Serratus Plane Block (SPB)Experimental treatment 1 intervention
Group C: Botulinum Toxin A (Botox-A) InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks after treatment initiation, or the closest measurement within +/- 1 week if the 8-week data is missing.

Secondary outcomes

1

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.

Time frame
Assessed at 8 weeks post-treatment.
2

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).

Time frame
Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
3

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).

Time frame
Assessed at multiple time points: 1, 2, 4, 6, 8, and 24 weeks.
4

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.

Time frame
Assessed at 7 and 14 days post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Oscar Lambret

Lead sponsor

Ligue contre le cancer, France

Collaborator

Santelys Association

Collaborator

CTD-CNO, Caen

Collaborator

Source ClinicalTrials.gov
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