Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 97WHK0900049 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.
Experimental and clinical studies have shown that surgical trauma and stress affects the immune system including both the innate and adaptive immune responses.
The break of immune homeostasis might enhance tumor growth and spread. Minimal invasive surgical procedures have been shown to be beneficial to patients in terms of preserving better systemic immune function. Impaired cellular immunity after general anesthesia has significant undesirable effects on tumor surveillance after breast surgery. The local block technique might avoid the surgery inducing neuroendocrine, metabolic, and cytokine responses, which will offer some advantages from better preservation of early postoperative cellular immune function and attenuate disturbance in the inflammatory mediators. Our research will focus on the effects of local block anesthesia on mediators that may be important in inflammatory response, tumor cell dissemination, deposition, and propagation in the early postoperative period. As importantly, local block method is not only a safe procedure but also reduces the need for post operative opioids and prevents nausea following breast cancer which can result in markedly reduced hospital stay and health costs. It is plausible that inhibition of the surgical responses by local block anesthesia may attenuate perioperative tumor enhancing factors and/or potential beneficial actions of lidocaine infiltration combined with propofol sedation per se in anticancer effect to have better cancer control.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local anesthesia | Active Comparator | local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level) |
|
| General anesthesia | Active Comparator | Patients receiving general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthesia | Procedure | All patients will be then given adequate sedation with propofol and local anesthetic given by dermal infiltration in incision site and regional breast and axillary areas. The local anesthetic of choice will be 2 % lidocaine (Xylocaine) and 0.5% Bupivacaine (Marcaine) mixed with 7 % sodium bicarbonate and epinephrine (Bosmine) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) pain scores | Until PACU discharge and for 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | 5 years | |
| Episodes of nausea or vomiting | 24 hours | |
| Overall patient satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Ching Chang, MD | Contact | 886-2-25433535 | yuanching.chang@gmail.com | |
| Yuan-Ching Chang, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| YuanChing Chang, MD | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay memorial hospital | Recruiting | Taipei | 10449 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40772525 | Derived | Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| General anesthesia | Procedure | The method of general anesthesia for the GA group will be induced with fentanyl (1-2 μg/kg) and propofol (2.5 mg/kg). After placement of a laryngeal mask or endotracheal tube airway, anesthesia will be maintained with sevoflurane (end-tidal concentrations 1%-3%) in a 50% oxygen/nitrous oxide mixture. |
|
|
| After hospital discharge and six months later |
| The need for postoperative opioids | 24 hours |
| D017437 |
| Skin and Connective Tissue Diseases |