ASST GOM Niguarda
Milan, Lombardy, 20162, Italy
NCT Number: NCT05876390
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
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All sexes
Observational
Milan, Lombardy, 20162, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Breast surgery
Multimodal analgesia
Other names: • loco-regional analgesia + NSAIDs, paracetamol
Time frame: 6 - 12 months
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)
Time frame: 2, 6, 12 and 24 hours
Acute postoperative pain. NRS Numerical Rating Scale (0-10; 0 =better 10= worse outcome)
Time frame: 3,6,9,12 months) at rest and on mobilization
Pain both at rest and on mobilization month3, month6, month9 and month12 after surgery. Numerical Rating Scale (0-10; 0 =better 10= worse outcome)
Time frame: Quality of recovery score (QoR 15)
Quality of recovery score-15 (QoR 15; scale 0-150; 0=better 150=worse outcome)
Time frame: Intraoperative
Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)
Time frame: hour2, hour 6, hour 12 and hour 24 after surgery
Postoperative opioid use. (opioid oral morphine milligram equivalent (MME); the lesser the better)
Niguarda Hospital
Other
Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
Acronym: IRACPoP
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