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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04540055
Other study ID # UNUD-CTR-FK300820-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 21, 2021

Study information

Verified date January 2021
Source Udayana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date January 21, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
Paravertebral block
The subjects in this group received general anesthesia and USG-guided paravertebral block
General Anesthesia
The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.

Locations

Country Name City State
Indonesia Sanglah General Hospital Denpasar Bali

Sponsors (1)

Lead Sponsor Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of IL-2 in blood serum Concentration of IL-2 level in blood serum 1-hour after surgery
Primary Concentration of IL-2 in blood serum Concentration of IL-2 level in blood serum 24-hours after surgery
Primary Concentration of IL-6 in blood serum Concentration of IL-6 level in blood serum 1-hour after surgery
Primary Concentration of IL-6 in blood serum Concentration of IL-6 level in blood serum 24-hours after surgery
Primary 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 Concentration of PGE2 level in blood serum Concentration of PGE2 level in blood serum 1-hour after surgery
Secondary Concentration of PGE2 level in blood serum Concentration of PGE2 level in blood serum 24-hours after surgery
Secondary Concentration of MMP-9 level in blood serum Concentration of MMP-9 level in blood serum 1-hour after surgery
Secondary Concentration of MMP-9 level in blood serum Concentration of MMP-9 level in blood serum 24-hours after surgery
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