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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04540055

Enrollment

Registered

2020-09-07

Start date

2020-10-01

Completion date

2021-01-21

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

PROCEDUREParavertebral block

The subjects in this group received general anesthesia and USG-guided paravertebral block

PROCEDUREGeneral Anesthesia

The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Concentration of PGE2 level in blood serum	1-hour after surgery	Concentration of PGE2 level in blood serum
Concentration of MMP-9 level in blood serum	1-hour after surgery	Concentration of MMP-9 level in blood serum

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026