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Clinical Trials/NCT04540055
NCT04540055
Completed
Not Applicable

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

Udayana University1 site in 1 country88 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Udayana University
Enrollment
88
Locations
1
Primary Endpoint
Concentration of IL-2 in blood serum
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
January 21, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Christopher Ryalino

Lecturer

Udayana University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Concentration of IL-2 in blood serum

Time Frame: 24-hours after surgery

Concentration of IL-2 level in blood serum

Visual Analog Scale (VAS)

Time Frame: 24-hours after surgery

pain score measured by visual analog scale (VAS), scaled between 0 (no pain) and 10 (worst pain)

Concentration of IL-6 in blood serum

Time Frame: 24-hours after surgery

Concentration of IL-6 level in blood serum

Secondary Outcomes

  • Concentration of MMP-9 level in blood serum(24-hours after surgery)
  • Concentration of PGE2 level in blood serum(24-hours after surgery)

Study Sites (1)

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