Clinical trial · Observational
Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )
Prospective Unicentre Non-randomised Study: Comparison of Postoperative Pain After Breast Cancer-typical Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia - TLA 001
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma in Situ | Breast Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General Anaesthesia | Procedure | — | UNRESOLVED |
| Local tumescent anaesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Surgery carried out according to clinical routine under general anaesthesia.
- interventionNames
- Procedure: General Anaesthesia
- label
- Local Anaesthesia Group
- description
- Surgery carried out under local tumescent anaesthesia. Procedure
- interventionNames
- Procedure: Local tumescent anaesthesia
Primary outcomes (1)
- measure
- Postoperative Pain
- timeFrame
- 5 weeks
- description
- The primary endpoint is the recording of postoperative pain. Pain will be measured on 1.-3. postoperative day using the Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Additionally, the postoperative pain will be assessed using the VAS at the post-operative follow-up consultation, which usually takes place 2-5 weeks after surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available