Impact of Regional Anesthesia on Chronic Post-operative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast surgery, analgesia.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
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%. 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
Interventions
- Procedure Breast surgery
Breast surgery - Drug analgesia
Multimodal analgesia
Primary outcome measures
- Incidence of chronic postoperative pain after major breast surgery [Time frame: 6 - 12 months]
Secondary outcome measures (5)
- Acute post-operative pain [Time frame: 2, 6, 12 and 24 hours]
- Chronic post-operative pain [Time frame: 3,6,9,12 months) at rest and on mobilization]
- Quality of life score [Time frame: Quality of recovery score (QoR 15)]
- Remifentanyl [Time frame: Intraoperative]
- Opioid [Time frame: hour2, hour 6, hour 12 and hour 24 after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- ASST GOM Niguarda — Milan
Identifiers
NCT: NCT05876390 · 603-11102022