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

NCT ID: NCT06335108

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 349 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Breast Carcinoma; Breast Carcinoma in Situ

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group

Surgery carried out according to clinical routine under general anaesthesia.

General Anaesthesia

Intervention Type: PROCEDURE

Breast surgery is carried out under general anesthesia.

Local Anaesthesia Group

Surgery carried out under local tumescent anaesthesia. Procedure

Local tumescent anaesthesia

Intervention Type: PROCEDURE

Breast surgery is carried out under local tumescent anesthesia.

Interventions

General Anaesthesia

Breast surgery is carried out under general anesthesia.

Intervention Type: PROCEDURE

Local tumescent anaesthesia

Breast surgery is carried out under local tumescent anesthesia.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Böer, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

University Women's Hospital

Tübingen, , Germany

Countries

Germany

Other Identifiers

SenoEx_TLA_Maligne

Identifier Type: -

Identifier Source: org_study_id