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

PHASE2RecruitingINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

August 30, 2027

Study Completion Date

December 30, 2027

Conditions
Post-Mastectomy Neuropathic Pain Syndrome
Interventions
DRUG

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

PROCEDURE

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 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.

PROCEDURE

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

Trial Locations (1)

59000

RECRUITING

Centre Oscar Lambret, Lille

All Listed Sponsors
collaborator

Ligue contre le cancer, France

OTHER

collaborator

Santelys Association

OTHER

collaborator

CTD-CNO, Caen

UNKNOWN

lead

Centre Oscar Lambret

OTHER

NCT06807164 - Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome | Biotech Hunter | Biotech Hunter