General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy

Study Overview
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Brief Summary
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Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.

Official Title
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Effects of General Anesthesia vs. General Anesthesia and Paravertebral Block to IL-2, IL-6, PGE2, MMP-9, and Clinical Outcome in Modified Radical Mastectomy

Conditions
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Anesthesia, Local, Anesthesia, Inflammatory Response, Pain, Postoperative

Intervention / Treatment
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* Procedure: Paravertebral block
* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery Balinese race ASA physical status I, II, III Exclusion Criteria: History of allergy to drugs used in anesthesia History psychiatric disorder History of perioperative transfusion History of autoimmune disease History of taking beta blockers or anti-platelet aggregation medications Previous breast surgery Spine deformity Coagulopathy Local infections in paravertebral block site Decreased renal function Neurological deficits Peptic ulcer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paravertebral (Group P)<br>Patients underwent MRM under the combination of general anesthesia and paravertebral block. | Procedure: Paravertebral block<br>* The subjects in this group received general anesthesia and USG-guided paravertebral block<br>|
| General Anesthesia (Group G)<br>Patients underwent MRM under general anesthesia. | Procedure: General Anesthesia<br>* The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of IL-2 in blood serum | Concentration of IL-2 level in blood serum | 1-hour after surgery | 
| Concentration of IL-2 in blood serum | Concentration of IL-2 level in blood serum | 24-hours after surgery | 
| Concentration of IL-6 in blood serum | Concentration of IL-6 level in blood serum | 1-hour after surgery | 
| Concentration of IL-6 in blood serum | Concentration of IL-6 level in blood serum | 24-hours after surgery | 
| Visual Analog Scale (VAS) | pain score measured by visual analog scale (VAS), scaled between 0 (no pain) and 10 (worst pain) | 24-hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of PGE2 level in blood serum | Concentration of PGE2 level in blood serum | 1-hour after surgery | 
| Concentration of PGE2 level in blood serum | Concentration of PGE2 level in blood serum | 24-hours after surgery | 
| Concentration of MMP-9 level in blood serum | Concentration of MMP-9 level in blood serum | 1-hour after surgery | 
| Concentration of MMP-9 level in blood serum | Concentration of MMP-9 level in blood serum | 24-hours after surgery |