Breast CancerESPNCT04689945
Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery
An observational study of Breast Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Morphine and Erector Spinae Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Chronic obstructive pulmonary disease
- Presence of infection at the time of surgery
- Hypothalamus, Pituitary, adrenal gland dysfunction
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital
Ankara, 06200
About this study
Official title: Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery
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.
Read the 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
- Being tested
- Morphine, Erector Spinae Block, Control
- Keywords
- erector spinae plane block, breast cancer, anesthesia and cancer, nerve block and cancer, cancer prognosis
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Opioid
PREOPERATIVE ANALGESIA: None
INTRAOPERATİVE ANALGESIA:
- Paracetamol 1000 mg IV
- Morphine 0,1 mg/kg IV
POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol
Erector Spinae BlockProcedure or surgery
Also called Plane block
PREOPERATIVE ANALGESIA:
Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection
INTRAOPERATİVE ANALGESIA:
- Paracetamol 1000 mg IV
- dexketoprofen 50 mg IV
POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol
ControlDrug
Also called other
PREOPERATIVE ANALGESIA: none
INTRAOPERATİVE ANALGESIA:
- Paracetamol 1000 mg IV
- Dexketoprofen 50 mg IV
POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Morphine | 30 patients who received intravenous morphine intraoperatively, without regional block application Receives: Drug: Morphine | |
| Erector Spinae Block | 30 patients who had preoperative esp block but did not use morphine during or after surgery Receives: Procedure: Erector Spinae Block | |
| Control | 30 patients who received multimodal analgesia methods other than ESP block or IV morphine Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
The investigators will measure VEGF preoperative(baseline), postoperative hour 24 from blood analysis.
Normal ranges of serum VEGF were 62-707 pg/ml.
Measured: 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).
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: End of surgery up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Feb 2021
- Primary completion1 May 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Ekin GÜRAN AYTUĞ. MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- hazal ekin güran aytug, resident, Principal investigator, Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689945
- Sponsor's protocol ID
- 2020-12/898
- Acronym
- ESP
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report
Publications
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.
PubMed 27865536Bates 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.
PubMed 29751789Sen 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.
PubMed 31764844Maher 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.
PubMed 31626971Gurkan 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.
PubMed 29980005Demirci 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.
PubMed 22940539Sultan 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.
PubMed 24348286Deegan 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.
PubMed 20975461Sen 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.
PubMed 31791567Forget 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.
PubMed 31035321
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04689945
- Acronym / sponsor ID
- ESP / 2020-12/898
- Conditions
- Breast Cancer
- Keywords
- erector spinae plane block, breast cancer, anesthesia and cancer, nerve block and cancer, cancer prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morphine | – | Drug: Morphine30 patients who received intravenous morphine intraoperatively, without regional block application |
| Erector Spinae Block | – | Procedure: Erector Spinae Block30 patients who had preoperative esp block but did not use morphine during or after surgery |
| Control | – | Drug: Control30 patients who received multimodal analgesia methods other than ESP block or IV morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: OpioidPREOPERATIVE 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 | Drug | Morphine |
| Erector Spinae BlockAlso: Plane blockPREOPERATIVE 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 | Procedure or surgery | Erector Spinae Block |
| ControlAlso: otherPREOPERATIVE ANALGESIA: none INTRAOPERATİVE ANALGESIA: 1. Paracetamol 1000 mg IV 2. Dexketoprofen 50 mg IV POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol | Drug | Control |
Primary outcome
Metabolomic profiling of ESP block for breast cancer surgery
Time frame: 24 hours postoperatively
Metabolomic profiling of 3 groups will be performed with liquid chromatography mass spectrometrt (LCMS) and Quadrupole time-of-flight (Q-TOF).
5 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: End of surgery up to 24 hours postoperatively
Tramadol consumption between the ESP block group and the control group
Time frame: End of surgery up to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 27865536Harbeck 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.
- Background: PubMed 29751789Bates 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.
- Background: PubMed 31764844Sen 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.
- Background: PubMed 31626971Maher 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.
- Background: PubMed 29980005Gurkan 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.
- Background: PubMed 22940539Demirci 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.
- Background: PubMed 24348286Sultan 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.
- Background: PubMed 20975461Deegan 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.
- Background: PubMed 31791567Sen 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.
- Background: PubMed 31035321Forget 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.
- Individual participant dataSharing planned: Yes. The investigators will share Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hazal ekin güran aytug, resident principal investigator
Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic profiling of ESP block for breast cancer surgery (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689945, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.