Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )

University Hospital Tuebingen

Status: Completed

Conditions: Breast Carcinoma in Situ; Breast Carcinoma

Treatments: Procedure: Local tumescent anaesthesia; Procedure: General Anaesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT06335108

SenoEx_TLA_Maligne

Details and patient eligibility

About

The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery.

Enrollment: 349 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Written informed consent
• Histologically confirmed breast carcinoma or pure ductal carcinoma in situ
• Planned operation:
• Segmental resection/ breast-conserving surgery
• Segmental resection/ breast-conserving surgery with SNB
• Ablatio
• Ablatio with SNB/ axilla exploration

Exclusion criteria

• Expected lack of patient compliance or inability of the patient to understand the purpose of the study
• Lack of patient consent
• Pregnancy
• Complete axillary dissection
• Tumour-adapted reduction surgery, implant reconstructions
• Surgeries where technical difficulties are expected under any anaesthesia (e.g. ASA IV, BMI > 40)
• Bilateral breast operations
• Men

Exclusion Criteria for surgery in TLA:

• Injection phobia
• Psychoses/ previous psychological illnesses
• Advanced dementia
• Language barrier

Trial design

349 participants in 2 patient groups

Control Group

Description:

Surgery carried out according to clinical routine under general anaesthesia.

Treatment:

Procedure: General Anaesthesia

Local Anaesthesia Group

Description:

Surgery carried out under local tumescent anaesthesia. Procedure

Treatment:

Procedure: Local tumescent anaesthesia