Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Niguarda Hospital
- Enrollment
- 1,500
- Locations
- 2
- Primary Endpoint
- Incidence of chronic postoperative pain after major breast surgery
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Patients undergoing oncological breast surgery
- mastectomy + reconstruction
- simple quadrantectomy
- quadrantectomy + sentinel lymph node biopsy
- quadrantectomy + axillary hollowing
- bilateral interventions will also be considered
Intervention: Breast surgery (Procedure)
Patients undergoing oncological breast surgery
- mastectomy + reconstruction
- simple quadrantectomy
- quadrantectomy + sentinel lymph node biopsy
- quadrantectomy + axillary hollowing
- bilateral interventions will also be considered
Intervention: analgesia (Drug)
Outcomes
Primary Outcomes
Incidence of chronic postoperative pain after major breast surgery
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)
Secondary Outcomes
- Quality of life score(Quality of recovery score (QoR 15))
- Opioid(hour2, hour 6, hour 12 and hour 24 after surgery)
- Acute post-operative pain(2, 6, 12 and 24 hours)
- Chronic post-operative pain(3,6,9,12 months) at rest and on mobilization)
- Remifentanyl(Intraoperative)