Clinical trial · Observational
Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery
Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery
NCT04689945CI-TRIAL-00063332ESPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Drug | — | UNRESOLVED |
| Erector Spinae Block | Procedure | — | UNRESOLVED |
| Morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Morphine
- description
- 30 patients who received intravenous morphine intraoperatively, without regional block application
- interventionNames
- Drug: Morphine
- label
- Erector Spinae Block
- description
- 30 patients who had preoperative esp block but did not use morphine during or after surgery
- interventionNames
- Procedure: Erector Spinae Block
- label
- Control
- description
- 30 patients who received multimodal analgesia methods other than ESP block or IV morphine
- interventionNames
- Drug: Control
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion criteria: 1. Should be female 2. Should be between 18-65 years old 3. Diagnosed with unilateral primary breast cancer 4. Are decided to have mastectomy surgery 5. Stage 1-2 breast cancer (T0-1-2, N0-1, M0) Exclusion criteria from the: 1. Being allergic to the anesthetics 2. Previously had breast operation other than diagnostic biopsy 3. Presence of a malignancy history on the other breast 4. Diagnosed with Inflammatory breast cancer 5. Having a risk score of The American Society of Anaesthesiologists (ASA) risk score 3 and above 6. Contraindications for regional block(Allergies for local anesthetics, Anatomic application difficulties, Coagulopathies) 7. Hormone usage 8. NRS score greater than 3 before the operation 9. Opioid or steroid usage before the operation 10. Rheumatologic history 11. Sickness or drug usage that might cause immunosuppression 12. Chemotherapy and/or radiotherapy history 13. Concomitant history of previous malignancy 14. History of Coronary Artery Disease, Peripheral Vascular Disease that may affect VEGF 15. Chronic smoking 16. Chronic obstructive pulmonary disease 17. Presence of infection at the time of surgery 18. Hypothalamus, Pituitary, adrenal gland dysfunction 19. Autoimmune diseases
References
Publications (10)
- BACKGROUNDHarbeck 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
- BACKGROUNDBates 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
- BACKGROUNDSen 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
- BACKGROUNDMaher 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
- BACKGROUNDGurkan 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
- BACKGROUNDDemirci 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
- BACKGROUNDSultan 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.