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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540055
• Other study ID #: UNUD-CTR-FK300820-004
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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