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

U

Udayana University

Status

Completed

Conditions

Anesthesia, Local
Inflammatory Response
Pain, Postoperative
Anesthesia

Treatments

Procedure: General Anesthesia
Procedure: Paravertebral block

Study type

Observational

Funder types

Other

Identifiers

NCT04540055
UNUD-CTR-FK300820-004

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

88 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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