Clinical trial

Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study

Name

603-11102022

Description

Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%. This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery

Trial arms

Trial start

2022-09-01

Estimated PCD

2024-09-30

Trial end

2025-09-30

Treatment

Breast surgery

Arms:

Patients undergoing oncological breast surgery

analgesia

Multimodal analgesia

Arms:

Patients undergoing oncological breast surgery

Other names:

• loco-regional analgesia + NSAIDs, paracetamol

Size

1500

Primary endpoint

Incidence of chronic postoperative pain after major breast surgery

6 - 12 months

Eligibility criteria

Inclusion criteria * Age \> 18 * Oncological breast surgery: * simple mastectomy, * mastectomy + sentinel lymph node biopsy, * mastectomy + axillary hollowing, * mastectomy + reconstruction, * simple quadrantectomy, * quadrantectomy + sentinel lymph node biopsy, * quadrantectomy + axillary hollowing, * bilateral interventions will also be considered) Exclusion * Age \< 18

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}

Updated at

2023-11-09

1 organization

1 product

1 indication

Organization

Niguarda Hospital

Product

analgesia

Indication

Breast Cancer