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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia, Local; Inflammatory Response; Anesthesia
• Intervention / Treatment: Procedure: Paravertebral block; Procedure: General Anesthesia

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Sanglah General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients with breast cancer (stadium Ia-IIIb) who underwent MRM surgery under general anesthesia in Sanglah General Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: UNUD-CTR-FK300820-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No