Impact of Regional Anesthesia on Chronic Post-operative Pain

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Breast surgery
* Drug: analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing oncological breast surgery<br>mastectomy + reconstruction simple quadrantectomy quadrantectomy + sentinel lymph node biopsy quadrantectomy + axillary hollowing bilateral interventions will also be considered | Procedure: Breast surgery<br>* Breast surgery<br>Drug: analgesia<br>* Multimodal analgesia<br>* Other names: • loco-regional analgesia + NSAIDs, paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic postoperative pain after major breast surgery | 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) | 6 - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute post-operative pain | Acute postoperative pain. NRS Numerical Rating Scale (0-10; 0 =better 10= worse outcome) | 2, 6, 12 and 24 hours | 
| Chronic post-operative pain | Pain both at rest and on mobilization month3, month6, month9 and month12 after surgery. Numerical Rating Scale (0-10; 0 =better 10= worse outcome) | 3,6,9,12 months) at rest and on mobilization | 
| Quality of life score | Quality of recovery score-15 (QoR 15; scale 0-150; 0=better 150=worse outcome) | Quality of recovery score (QoR 15) | 
| Remifentanyl | Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better) | Intraoperative | 
| Opioid | Postoperative opioid use. (opioid oral morphine milligram equivalent (MME); the lesser the better) | hour2, hour 6, hour 12 and hour 24 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast surgery, oncological breast surgery, multimodal analgesia, chronic postoperative pain