Symptoms and General Pathology

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Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Central Nervous System Depressants

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Analgesics

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Analgesics, Non-Narcotic

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

Breast surgery

analgesia

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

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

Impact of Regional Anesthesia on Chronic Post-operative Pain

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

The results obtained will be used for a scientific publication and for the elaboration of a specialist degree thesis in Anesthesia and Intensive Care

Incidence of chronic post-surgical pain after major breast surgery (definition: pain that persists at least 3 months after surgery; pain that was not present before surgery or that has different characteristics from pain before surgery or that has increased intensity than before the operation; the pain is localized in the area of the surgical site or in its radiation; other possible causes of pain are excluded)

Acute postoperative pain. NRS Numerical Rating Scale (0-10; 0 =better 10= worse outcome)

Pain both at rest and on mobilization month3, month6, month9 and month12 after surgery. Numerical Rating Scale (0-10; 0 =better 10= worse outcome)

Quality of recovery score-15 (QoR 15; scale 0-150; 0=better 150=worse outcome)

Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)

Postoperative opioid use. (opioid oral morphine milligram equivalent (MME); the lesser the better)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Regional Anesthesia on Chronic Post-operative Pain	NCT05876390	Breast Cancer	Breast surgery analgesia	18 Years -	Niguarda Hospital
Impact of Regional Anesthesia on Chronic Post-operative Pain	NCT05876390	Breast Cancer	Breast surgery analgesia	18 Years -	Niguarda Hospital

Spots Global Cancer Trial Database for oncological breast surgery