Clinical trial NCT06335108: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )
Official title: Prospective Unicentre Non-randomised Study: Comparison of Postoperative Pain After Breast Cancer-typical Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia - TLA 001
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Breast Carcinoma in Situ
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients presenting with invasive breast carcinoma or pure ductal carcinoma in situ with an indication for surgical treatment at the Department of Women's Health in Tübingen.

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.


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

Exclusion Criteria for surgery in TLA:

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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 5 weeks
Secondary outcomes:
measure: HRQoL/ Quality of life
timeFrame: 5 weeks
measure: Postoperative pain medication requirements
timeFrame: 5 weeks
measure: Complications
timeFrame: 5 weeks
measure: Length of hospital stay
timeFrame: 1 day until 2 weeks
measure: Duration of surgery
timeFrame: 1 until 5 hours
measure: Drainage delivery rate
timeFrame: Surgery until discharge (1 day until 2 weeks )
measure: Follow-up surgery for R1 situation
timeFrame: 5 hours
measure: Preoperative fear of surgery and anaesthesia
timeFrame: 30 Minutes
measure: Costs
timeFrame: 5 weeks
measure: Satisfaction of the surgeon with the course of the operation
timeFrame: 5 hours
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Women's Hospital
Study officials:
affiliation: University Hospital Tübingen
name: Bettina Böer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: