Impact of Regional Anesthesia on Chronic Post-operative Pain (IRACPoP)

Niguarda Hospital

Status: Invitation-only

Conditions: Breast Cancer

Treatments: Procedure: Breast surgery; Drug: analgesia

Study type: Observational

Funder types: Other

Identifiers

NCT05876390

603-11102022

Details and patient eligibility

About

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

Full 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%.Persistent postsurgical pain, defined in the ICD-11 as pain that develops or increases in intensity after a surgical procedure or tissue damage and persists beyond the healing process for at least 3 months after the initial event and is considered a complication of surgery.

Several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions, including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia.

The purpose of this multicenter prospective observational study is to evaluate, through the propensity score methodology, how much the use of loco-regional anesthesia techniques can improve the outcome, in terms of the development of chronic post-surgical pain, of patients undergoing to oncological breast surgery

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,500 participants in 1 patient group

Patients undergoing oncological breast surgery

Description:

* mastectomy + reconstruction * simple quadrantectomy * quadrantectomy + sentinel lymph node biopsy * quadrantectomy + axillary hollowing * bilateral interventions will also be considered

Treatment:

Drug: analgesia

Procedure: Breast surgery