Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | 30 patients who received intravenous morphine intraoperatively, without regional block application |
| |
| Erector Spinae Block | 30 patients who had preoperative esp block but did not use morphine during or after surgery |
| |
| Control | 30 patients who received multimodal analgesia methods other than ESP block or IV morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | PREOPERATIVE ANALGESIA: None INTRAOPERATİVE ANALGESIA:
POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). | 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 |
Not provided
Inclusion criteria:
Exclusion criteria from the:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| hazal ekin güran aytug, resident | Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital | Ankara | 06200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27865536 | Background | 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. | |
| 29751789 | 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. |
Not provided
Not provided
The investigators will share Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report
Data will become available starting 6 months from publication.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
blood sample
|
| Erector Spinae Block | Procedure | PREOPERATIVE ANALGESIA: Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection INTRAOPERATİVE ANALGESIA:
POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol |
|
|
| Control | Drug | PREOPERATIVE ANALGESIA: none INTRAOPERATİVE ANALGESIA:
POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol |
|
|
| 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). | 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). | 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. | 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 | The investigators will record total opioid consumption via Patient-Controlled Analgesia devices. | End of surgery up to 24 hours postoperatively |
| 31764844 | 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. |
| 31626971 | 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. |
| 29980005 | 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. |
| 22940539 | 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. |
| 24348286 | 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. |
| 20975461 | 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. |
| 31791567 | 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. |
| 31035321 | 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. |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |