Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery (ESP)

January 17, 2023 updated by: Hazal Ekin GÜRAN AYTUĞ. MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery

Worldwide, breast cancer is the most common cancer among women, and its incidence and mortality rates are expected to increase significantly in the next years. It remains a major health problem. There is a vast area on breast cancer and immunity that still needs to be researched. Do anesthetic techniques and medication preferences effect immune responses? If so how they effect breast cancer outcomes is unclear.

On this trial, the investigators are searching anesthetic techniques affect on inflammatory and immune responses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most frequently encountered surgery among all cancer surgeries. Although it is a well known procedure for anesthesiologists, it is still unclear whether anesthesiology effects immune responses. Cancer therapies often use immune therapies such as Bevacizumab (a monoclonal antibody which targets Vascular Endothelial Growth Factor), Trastuzumab(a monoclonal antibody for Herceptin (HER2/Neu) mutation) how anesthetics effect VEGF stays unclear.

Opioids are commonly used to provide analgesia for cancer pain, and functional opioid receptors have been identified on natural killer (NK) cells, the lymphocytes responsible for surveillance and elimination of cancer cells.[4] Anesthesiologists have well founded concerns about using morphine during cancer surgeries.

Regional anesthetic techniques commonly used on cancer surgeries.The activation of sensory neurons during pain enhances tumor progression and metastatic potential. Regional anesthesia blocks somatic nociception and inhibits sympathetic preganglionic outflow (functional sympathectomy) during surgery. Moreover regional anesthesia, by blocking sympathetic nervous system output, induces a prevalence of parasympathetic tone. Local anesthetics can also modulate autonomic receptors. For these reasons, more studies are needed to investigate the action of regional anesthetic neuromodulation on cancer progression.[11]

The Erector Spinae Plane Block (ESP block) is most often performed on thoracic paraspinal levels, causes sympathetic blockage. Sympathetic block has been studied on central neuraxial blocks but the sympathetic block caused by the ESP block and immune responses remain unclear.

Sympathetic block inhibits hyperbolic immune responses after surgery, therefore enhances postoperative rate of acceleration on cytokine levels. The investigators propose that ESP block improves immune responses and improved immune responses have better clinical outcomes for patients with breast cancer. Improved immune responses decrease length of stay (LOS), enhance postoperative recovery, analgesia and quality of life. Therefore allows better patient experience about procedures.

The investigators will take 90 patients who will undergo a breast cancer operation and compare vitals (heart rate, blood pressure, oxygen saturation), Numeric Rating Scales (NRS), Vascular Endothelial Growth Factor (VEGF) responses, systemic immune inflammatory indexes, cortisol levels, CRP and Procalcitonin levels between three groups; opioid analgesia group(group M), ESP block group(group E), non-opioid non-ESP group (group P).

The investigators' main focus is immune alterations after anesthesia techniques. Anesthesiologist keep track of pain scores after surgery. this trials secondary outcome focuses on pain management after surgery.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06200
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

The investigators will evaluate unilateral breast cancer patients from Ankara Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital who will undergo Mastectomy procedure.

The investigators will exclude patients who no longer want to participate at any part of the trial.

A total of 90 patients' data will be collected.

Description

Inclusion criteria:

  1. Should be female
  2. Should be between 18-65 years old
  3. Diagnosed with unilateral primary breast cancer
  4. Are decided to have mastectomy surgery
  5. Stage 1-2 breast cancer (T0-1-2, N0-1, M0)

Exclusion criteria from the:

  1. Being allergic to the anesthetics
  2. Previously had breast operation other than diagnostic biopsy
  3. Presence of a malignancy history on the other breast
  4. Diagnosed with Inflammatory breast cancer
  5. Having a risk score of The American Society of Anaesthesiologists (ASA) risk score 3 and above
  6. Contraindications for regional block(Allergies for local anesthetics, Anatomic application difficulties, Coagulopathies)
  7. Hormone usage
  8. NRS score greater than 3 before the operation
  9. Opioid or steroid usage before the operation
  10. Rheumatologic history
  11. Sickness or drug usage that might cause immunosuppression
  12. Chemotherapy and/or radiotherapy history
  13. Concomitant history of previous malignancy
  14. History of Coronary Artery Disease, Peripheral Vascular Disease that may affect VEGF
  15. Chronic smoking
  16. Chronic obstructive pulmonary disease
  17. Presence of infection at the time of surgery
  18. Hypothalamus, Pituitary, adrenal gland dysfunction
  19. Autoimmune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Morphine
30 patients who received intravenous morphine intraoperatively, without regional block application
Drug: Morphine

PREOPERATIVE ANALGESIA: None

INTRAOPERATİVE ANALGESIA:

  1. Paracetamol 1000 mg IV
  2. Morphine 0,1 mg/kg IV

POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol

Other Names:
  • Opioid
Erector Spinae Block
30 patients who had preoperative esp block but did not use morphine during or after surgery
Procedure: Erector Spinae Block

PREOPERATIVE ANALGESIA:

Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection

INTRAOPERATİVE ANALGESIA:

  1. Paracetamol 1000 mg IV
  2. dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Other Names:
  • Plane block
Control
30 patients who received multimodal analgesia methods other than ESP block or IV morphine
Drug: Control

PREOPERATIVE ANALGESIA: none

INTRAOPERATİVE ANALGESIA:

  1. Paracetamol 1000 mg IV
  2. Dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Other Names:
  • other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolomic profiling of ESP block for breast cancer surgery
Time Frame: 24 hours postoperatively
Metabolomic profiling of 3 groups will be performed with liquid chromatography mass spectrometrt (LCMS) and Quadrupole time-of-flight (Q-TOF).
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defining the change in preoperative (baseline), postoperative hour 24 Vascular Endothelial Growth Factor (VEGF) levels between the morphine group (group M), the ESP block group (group E), and the control group (group c).
Time Frame: change from baseline VEGF at 24 hours postoperatively

The investigators will measure VEGF preoperative(baseline), postoperative hour 24 from blood analysis.

Normal ranges of serum VEGF were 62-707 pg/ml.
change from baseline VEGF at 24 hours postoperatively
Defining the change in preoperative (baseline), postoperative hour 1, postoperative hour 24 cortisol levels between the morphine group (group M), the ESP block group (group E), and the control group (group c).
Time Frame: change from baseline cortisol up to 24 hours postoperatively

The investigators will measure cortisol preoperative(baseline),postoperative hour 1, postoperative hour 24 from blood analysis.

Serum cortisol normal range for adults 8 am to 4pm: 5-25 mcg/dL
change from baseline cortisol up to 24 hours postoperatively
Defining the change in preoperative (baseline), postoperative hour 1, postoperative hour 24 C-reactive Protein levels between the morphine group (group M), the ESP block group (group E), and the control group (group c).
Time Frame: change from baseline CRP up to 24 hours postoperatively

The investigators will measure CRP preoperative(baseline), postoperative hour 1, postoperative hour 24 from blood analysis.

CRP normal reading is less than 10mg/L.
change from baseline CRP up to 24 hours postoperatively
Defining analgesic effects between the morphine group (group M), the ESP block group (group E), and the control group (group c) on patients who had breast cancer surgery.
Time Frame: End of surgery up to 24 hours postoperatively

The investigators will evaluate patients' pain score with numeric rating scale (NRS) postoperative hour 1, 2, 12, 24 and compare NRS between the control group (group c), the ESP block group (group E) and intravenous morphine group (group M)

The investigators will compare NRS between two groups at postoperative hour 1, 2, 12, 24.

The most common form of NRS is a horizontal line with an eleven point numeric range, from 0 (patient with no pain) to 10 (patient with the worst pain possible).
End of surgery up to 24 hours postoperatively
Tramadol consumption between the ESP block group and the control group
Time Frame: End of surgery up to 24 hours postoperatively
The investigators will record total opioid consumption via Patient-Controlled Analgesia devices.
End of surgery up to 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Investigators

  • Principal Investigator: hazal ekin güran aytug, resident, Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

December 26, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-12/898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The investigators will share Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report

IPD Sharing Time Frame

Data will become available starting 6 months from publication.

IPD Sharing Access Criteria

IPD will be shared with other clinical experimenters in order to serve as an example to similar studies and to demonstrate the reliability of the study. Consent forms of the participants, preoperative evaluation and postoperative follow-up forms, blood results evaluating inflammatory responses, postoperative analgesia need follow-up form will be open to sharing.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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