NCT04540055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

August 31, 2020

Last Update Submit

January 20, 2021

Conditions

Anesthesia, LocalAnesthesiaInflammatory ResponsePain, Postoperative

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Concentration of PGE2 level in blood serum

    1-hour after surgery

  • Concentration of PGE2 level in blood serum

    24-hours after surgery

  • Concentration of MMP-9 level in blood serum

    1-hour after surgery

  • Concentration of MMP-9 level in blood serum

    24-hours after surgery

Study Arms (2)

Paravertebral (Group P)

Patients underwent MRM under the combination of general anesthesia and paravertebral block.

Procedure: Paravertebral block

General Anesthesia (Group G)

Patients underwent MRM under general anesthesia.

Procedure: General Anesthesia

Interventions

Paravertebral blockPROCEDURE

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

Paravertebral (Group P)
General AnesthesiaPROCEDURE

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

General Anesthesia (Group G)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
  • Balinese race
  • ASA physical status I, II, III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

October 1, 2020

Primary Completion

December 30, 2020

Study Completion

January 21, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

ID(1)