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

NCT06335108 | Completed

• 1 other identifier: SenoEx_TLA_Maligne
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  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.

  5 weeks

Secondary Outcomes (10)

• HRQoL/ Quality of life

  5 weeks

• Postoperative pain medication requirements

  5 weeks

• Complications

  5 weeks

• Length of hospital stay

  1 day until 2 weeks

• Duration of surgery

  1 until 5 hours

Study Arms (2)

Control Group

Surgery carried out according to clinical routine under general anaesthesia.

Procedure: General Anaesthesia

Local Anaesthesia Group

Surgery carried out under local tumescent anaesthesia. Procedure

Procedure: Local tumescent anaesthesia

Interventions

General Anaesthesia PROCEDURE

Breast surgery is carried out under general anesthesia.

Control Group

Local tumescent anaesthesia PROCEDURE

Breast surgery is carried out under local tumescent anesthesia.

Local Anaesthesia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Women's Hospital

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Bettina Böer, Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 28, 2024
• Study Start: December 5, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

DE (1)