NCT04689945

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

Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-01
• Completion: 2021-10-01
• First posted: 2020-12-30
• Last updated: 2023-01-19

Locations

1 site across 1 country: Turkey (Türkiye)