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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Breast Carcinoma
    Breast Carcinoma in Situ

NCT06335108

University Hospital Tuebingen

16 April 2024

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