Is it possible to surgically remove a breast tumor using only local anesthesia, and is this a viable alternative to general anesthesia?
- Gender
- Women
- Age
- 18 years and older
- Trial type
- Observational
- Line of therapy
- First line
- Phase
- —
What is this trial about?
Breast cancer confined to the breast is usually removed surgically. To date, this has been done under general anesthesia. An alternative method, which is already used for benign breast surgeries, employs a special form of local anesthesia—that is, without general anesthesia. In addition to avoiding potential side effects of general anesthesia, this could also have positive effects on postoperative pain. The goal of this study is to compare both procedures (local anesthesia and general anesthesia) in terms of postoperative pain. Women aged 18 and older with newly diagnosed breast cancer or a precancerous condition (carcinoma in situ) who are scheduled for breast-conserving surgery or a mastectomy (complete removal of the breast) are eligible to participate in this study.
Detailed description
Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors. In many cases, locally confined tumors can be surgically removed. This may involve breast-conserving surgery or a mastectomy (complete removal of the affected breast). General anesthesia is typically used for the surgery. This puts patients into a sleep-like state. Potential side effects and aftereffects—such as nausea, a longer recovery time, or complications related to intubation and anesthetics—are drawbacks. An alternative method is local anesthesia of the surgical site. A specific technique here is tumescent local anesthesia (TLA). In this procedure, the surgical site is infiltrated with a large volume of local anesthetic solution. The advantage is that the patient remains awake, thereby eliminating the general risks associated with general anesthesia. In addition, this procedure may offer benefits regarding postoperative pain.
The aim of this study is to investigate pain following surgery under tumescent local anesthesia and general anesthesia. For the study, patients are divided into two groups. Group 1 will receive general anesthesia for the surgery, and Group 2 will receive tumescent local anesthesia. The study is open-label, meaning that both the medical staff and the patient know which treatment is being administered. The primary endpoint is postoperative pain over a five-week observation period. Patients will rate their perceived pain on a visual analog scale during the first three days after surgery and two to five weeks after surgery.
Women aged 18 and older with newly diagnosed breast cancer or a precancerous condition (carcinoma in situ, e.g., DCIS, LCIS) who are scheduled for breast-conserving surgery or mastectomy are eligible to participate in this study. Bilateral surgery or breast reconstruction using implants must not be planned.
Facts
- What condition: Breast cancer (mammary carcinoma) or precancerous breast condition (carcinoma in situ, e.g., DCIS, LCIS)
- Cancer characteristics: newly diagnosed, planned breast-conserving surgery or mastectomy (complete removal of the affected breast)
- What the study investigates: Comparison of postoperative pain following tumescent local anesthesia (TLA) versus general anesthesia
- Study objective: To reduce postoperative pain through TLA
- Study duration: Postoperative follow-up for up to five weeks
- Study characteristics: Two treatment groups; open-label (unblinded)
Trial sites
1 trial site in Germany is listed.
University Women's Hospital
72076 Tübingen
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT06335108) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


