Impact of Regional Anesthesia on Chronic Post-operative Pain

Niguarda Hospital1,500 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Breast Cancer

Interventions

Breast surgeryPROCEDURE

Breast surgery

analgesiaDRUG

Multimodal analgesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ASST GOM Niguarda

Milan, Lombardy, Italy

Outcomes

Primary Outcomes

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)

Time frame: 6 - 12 months

Secondary Outcomes

Acute post-operative pain

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

Time frame: 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)

Time frame: 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)

Time frame: Quality of recovery score (QoR 15)

Remifentanyl

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

Time frame: Intraoperative

Opioid

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

Time frame: hour2, hour 6, hour 12 and hour 24 after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.