Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT04689945
- Lead Sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 91
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Erector Spinae Block Erector Spinae Block 30 patients who had preoperative esp block but did not use morphine during or after surgery Control Control 30 patients who received multimodal analgesia methods other than ESP block or IV morphine Morphine Morphine 30 patients who received intravenous morphine intraoperatively, without regional block application
- Primary Outcome Measures
Name Time Method Metabolomic profiling of ESP block for breast cancer surgery 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 Outcome Measures
Name Time Method Tramadol consumption between the ESP block group and the control group End of surgery up to 24 hours postoperatively The investigators will record total opioid consumption via Patient-Controlled Analgesia devices.
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 The investigators will measure CRP preoperative(baseline), postoperative hour 1, postoperative hour 24 from blood analysis.
CRP normal reading is less than 10mg/L.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 The investigators will measure VEGF preoperative(baseline), postoperative hour 24 from blood analysis.
Normal ranges of serum VEGF were 62-707 pg/ml.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 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/dLDefining 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 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).
Trial Locations
- Locations (1)
Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital
🇹🇷Ankara, Turkey