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

Completed

• Conditions: Anesthesia; Anesthesia, Local; Inflammatory Response; Pain, Postoperative
• Interventions: Procedure: General Anesthesia; Procedure: Paravertebral block

• Registration Number: NCT04540055
• Lead Sponsor: Udayana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-07
• Study Start: 2020-10-01
• Primary Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Study Completion: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Anesthesia (Group G)	General Anesthesia	Patients underwent MRM under general anesthesia.
Paravertebral (Group P)	Paravertebral block	Patients underwent MRM under the combination of general anesthesia and paravertebral block.

Primary Outcome Measures

Name	Time	Method
Concentration of IL-2 in blood serum	24-hours after surgery	Concentration of IL-2 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)
Concentration of IL-6 in blood serum	24-hours after surgery	Concentration of IL-6 level in blood serum

Secondary Outcome Measures

Name	Time	Method
Concentration of MMP-9 level in blood serum	24-hours after surgery	Concentration of MMP-9 level in blood serum
Concentration of PGE2 level in blood serum	24-hours after surgery	Concentration of PGE2 level in blood serum

Trial Locations

Locations (1)

Sanglah General Hospital; 🇮🇩 Denpasar, Bali, Indonesia