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

NCT04689945 | Completed

• 1 other identifier: 2020-12/898
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

erector spinae plane block; breast cancer; anesthesia and cancer; nerve block and cancer; cancer prognosis

Outcome Measures

Primary Outcomes (1)

• Metabolomic profiling of ESP block for breast cancer surgery

  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 Outcomes (5)

• 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).

  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).

  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).

  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.

  End of surgery up to 24 hours postoperatively

• Tramadol consumption between the ESP block group and the control group

  End of surgery up to 24 hours postoperatively

Study Arms (3)

Morphine

30 patients who received intravenous morphine intraoperatively, without regional block application

Drug: Morphine

Erector Spinae Block

30 patients who had preoperative esp block but did not use morphine during or after surgery

Procedure: Erector Spinae Block

Control

30 patients who received multimodal analgesia methods other than ESP block or IV morphine

Drug: Control

Interventions

Morphine DRUG

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

Also known as: Opioid

Morphine

Erector Spinae Block PROCEDURE

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

Also known as: Plane block

Erector Spinae Block

Control DRUG

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

Also known as: other

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (10)

• Harbeck N, Gnant M. Breast cancer. Lancet. 2017 Mar 18;389(10074):1134-1150. doi: 10.1016/S0140-6736(16)31891-8. Epub 2016 Nov 17.

  PMID: 27865536 BACKGROUND

• Bates JP, Derakhshandeh R, Jones L, Webb TJ. Mechanisms of immune evasion in breast cancer. BMC Cancer. 2018 May 11;18(1):556. doi: 10.1186/s12885-018-4441-3.

  PMID: 29751789 BACKGROUND

• Sen Y, Xiyang H, Yu H. Effect of thoracic paraspinal block-propofol intravenous general anesthesia on VEGF and TGF-beta in patients receiving radical resection of lung cancer. Medicine (Baltimore). 2019 Nov;98(47):e18088. doi: 10.1097/MD.0000000000018088.

  PMID: 31764844 BACKGROUND

• Maher DP, Walia D, Heller NM. Morphine decreases the function of primary human natural killer cells by both TLR4 and opioid receptor signaling. Brain Behav Immun. 2020 Jan;83:298-302. doi: 10.1016/j.bbi.2019.10.011. Epub 2019 Oct 15.

  PMID: 31626971 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Demirci U, Yaman M, Buyukberber S, Coskun U, Baykara M, Uslu K, Ozet A, Benekli M, Bagriacik EU. Prognostic importance of markers for inflammation, angiogenesis and apoptosis in high grade glial tumors during temozolomide and radiotherapy. Int Immunopharmacol. 2012 Dec;14(4):546-9. doi: 10.1016/j.intimp.2012.08.007. Epub 2012 Aug 29.

  PMID: 22940539 BACKGROUND

• Sultan SS. Paravertebral block can attenuate cytokine response when it replaces general anesthesia for cancer breast surgeries. Saudi J Anaesth. 2013 Oct;7(4):373-7. doi: 10.4103/1658-354X.121043.

  PMID: 24348286 BACKGROUND

• Deegan CA, Murray D, Doran P, Moriarty DC, Sessler DI, Mascha E, Kavanagh BP, Buggy DJ. Anesthetic technique and the cytokine and matrix metalloproteinase response to primary breast cancer surgery. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):490-5. doi: 10.1097/AAP.0b013e3181ef4d05.

  PMID: 20975461 BACKGROUND

• Sen S, Koyyalamudi V, Smith DD, Weis RA, Molloy M, Spence AL, Kaye AJ, Labrie-Brown CC, Morgan Hall O, Cornett EM, Kaye AD. The role of regional anesthesia in the propagation of cancer: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):507-522. doi: 10.1016/j.bpa.2019.07.004. Epub 2019 Jul 31.

  PMID: 31791567 BACKGROUND

• Forget P, Aguirre JA, Bencic I, Borgeat A, Cama A, Condron C, Eintrei C, Eroles P, Gupta A, Hales TG, Ionescu D, Johnson M, Kabata P, Kirac I, Ma D, Mokini Z, Guerrero Orriach JL, Retsky M, Sandrucci S, Siekmann W, Stefancic L, Votta-Vellis G, Connolly C, Buggy D. How Anesthetic, Analgesic and Other Non-Surgical Techniques During Cancer Surgery Might Affect Postoperative Oncologic Outcomes: A Summary of Current State of Evidence. Cancers (Basel). 2019 Apr 28;11(5):592. doi: 10.3390/cancers11050592.

  PMID: 31035321 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Morphine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• hazal ekin güran aytug, resident

  Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident, MD

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 30, 2020
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available starting 6 months from publication.
• 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.

Locations

TU (1)