NCT06910280

Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The conservative surgery for breast cancer is the first treatment for cancer and includes : * A partial mastectomy (removal of part of the breast) * A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast). This is a common procedure in the gynecology operating room, usually performed under general anesthesia. However, with surgical advancements and less invasive procedures, it has become possible and common for patients to undergo surgery in our department under local anesthesia. No data in the medical literature has yet evaluated this new anesthetic approach. Through this study, we aim to assess the feasibility and acceptability of partial mastectomy surgery with sentinel lymph node removal under either local anesthesia or general anesthesia. The ultimate goal of this study is to allow future patients to benefit from faster outpatient surgery, requiring less hospital stay, and to continue the progress of minimizing surgical interventions that has already been successfully undertaken in breast cancer treatment. This is an interventional study because it involves randomization, which determines for each enrolled patient whether they will receive general anesthesia or local anesthesia. It is a feasibility and acceptability study It is important to note that the surgery itself will not differ between the two groups: only the method of anesthesia will change. This research is being conducted at the University Hospital of Besançon and only at this center.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	conservative surgery for breast cancer with local anesthesia	conservative surgery for breast cancer with local anesthesia
PROCEDURE	conservative surgery for breast cancer with general anesthesia	conservative surgery for breast cancer with general anesthesia

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: France