Comparing pain after breast surgery using local anesthesia versus general anesthesia
Prospective Unicentre Non-randomised Study: Comparison of Postoperative Pain After Breast Cancer-typical Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia - TLA 001
This study tests if using local anesthesia instead of general anesthesia during breast cancer surgery can help reduce pain for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT06335108 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Tumescent Local Anesthesia (TLA) on pain perception in patients undergoing surgeries for breast cancer. Unlike general anesthesia, TLA allows patients to remain awake during the procedure, potentially reducing risks associated with general anesthesia. The research builds on previous findings that TLA is feasible for benign breast surgeries and aims to enhance surgical techniques and postoperative care for breast cancer procedures. Data collected will contribute to the understanding and application of TLA in this context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed breast carcinoma or ductal carcinoma in situ who are scheduled for specific types of breast surgeries.
Not a fit: Patients who may not benefit include those with severe obesity, certain psychological conditions, or those requiring more complex surgical interventions.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced complications for patients undergoing breast cancer surgeries.
How similar studies have performed: Previous studies have shown the feasibility of TLA in benign breast surgeries, suggesting potential for success in this novel application for breast cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tübingen
- University Women's Hospital — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Bettina Böer, Dr. — University Hospital Tübingen
- Study coordinator: Bettina Böer, Dr.
- Email: Bettina.Boeer@med.uni-tuebingen.de
- Phone: +49 7071 29 82211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.