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NCT Number: NCT04689945

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Ankara, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

from the:

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

Treatment and study plan

Morphine

Drug

PREOPERATIVE ANALGESIA: None

INTRAOPERATİVE ANALGESIA:

  • Paracetamol 1000 mg IV
  • Morphine 0,1 mg/kg IV

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

Other names: Opioid

erector spinae block

Procedure

PREOPERATIVE ANALGESIA:

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

INTRAOPERATİVE ANALGESIA:

  • Paracetamol 1000 mg IV
  • dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Other names: Plane block

Control

Drug

PREOPERATIVE ANALGESIA: none

INTRAOPERATİVE ANALGESIA:

  • Paracetamol 1000 mg IV
  • Dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Other names: other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery

Acronym: ESP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Jan 19, 2023

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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