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Completed

NCT Number: NCT04540055

General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes 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.

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Key information

Conditions

Anesthesia, Local Anesthesia Inflammatory Response Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paravertebral block

Procedure

The subjects in this group received general anesthesia and USG-guided paravertebral block

General Anesthesia

Procedure

The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.

Primary outcomes

  1. Concentration of IL-2 in blood serum

    Time frame: 1-hour after surgery

    Concentration of IL-2 level in blood serum

  2. Concentration of IL-2 in blood serum

    Time frame: 24-hours after surgery

    Concentration of IL-2 level in blood serum

  3. Concentration of IL-6 in blood serum

    Time frame: 1-hour after surgery

    Concentration of IL-6 level in blood serum

  4. Concentration of IL-6 in blood serum

    Time frame: 24-hours after surgery

    Concentration of IL-6 level in blood serum

  5. 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)

Secondary outcomes

  1. Concentration of PGE2 level in blood serum

    Time frame: 1-hour after surgery

    Concentration of PGE2 level in blood serum

  2. Concentration of PGE2 level in blood serum

    Time frame: 24-hours after surgery

    Concentration of PGE2 level in blood serum

  3. Concentration of MMP-9 level in blood serum

    Time frame: 1-hour after surgery

    Concentration of MMP-9 level in blood serum

  4. Concentration of MMP-9 level in blood serum

    Time frame: 24-hours after surgery

    Concentration of MMP-9 level in blood serum

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 7, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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