Impact of Regional Anesthesia on Chronic Post-operative Pain

Trial Title: Impact of Regional Anesthesia on Chronic Post-operative Pain

NCT ID: NCT05876390

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Acetaminophen

Conditions: Keywords:
breast cancer
breast surgery
oncological breast surgery
multimodal analgesia
chronic postoperative pain

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Breast surgery
Description: Breast surgery
Arm group label: Patients undergoing oncological breast surgery

Intervention type: Drug
Intervention name: analgesia
Description: Multimodal analgesia
Arm group label: Patients undergoing oncological breast surgery

Other name: • loco-regional analgesia + NSAIDs, paracetamol

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

Criteria for eligibility:

Study pop:
Patients undergoing oncological breast surgery

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: ASST GOM Niguarda

Address:
City: Milano
Zip: 20162
Country: Italy

Start date: September 1, 2022

Completion date: September 30, 2025

Lead sponsor:
Agency: Niguarda Hospital
Agency class: Other

Source: Niguarda Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05876390