Breast Cancer FemaleNCT04172220
Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?
A study testing Midazolam, PECS and Opioid-free general anesthesia in people with Breast Cancer Female, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Midazolam, PECS and Opioid-free general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2019to 1 Nov 2022
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First diagnosis of histologically confirmed breast cancer
- Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy)
- Able to provide adequate informed consent
- With intact cognitive abilities
Who cannot join
- Ongoing pregnancy
- In therapy or in follow-up for other cancers at the time of the study
- Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases
- History of documented allergy or previous adverse reaction to local anesthetics
- Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management
- Unable to comply to study protocol schedule for logistic or other reasons
- Refusal to participate to the study (absence of signed informed consent)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
Aviano, PN, 33081
About this study
Official title: Variation of the Neutrophil To Lymphocyte Ratio During Opioid-Free General Anesthesia Associated With Thoracic Wall Blocks Vs General Anesthesia, in Breast Cancer Quadrantectomy: a Randomized Controlled Trial
The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state.
This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.
- Conditions
- Breast Cancer Female
- Being tested
- Midazolam, PECS, Opioid-free general anesthesia, General anesthesia, Postoperative analgesia
- Keywords
- Breast Cancer, PECS, Neutrophil to Lymphocyte ratio, Quadrantectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
1-2 mg of Midazolam as premedication.
PECSProcedure or surgery
Loco-regional anesthesia: PEC I and serratus plane block with an echoguided technique.
For the PEC I: infiltration of 10 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of the pectoralis major muscle and the small pectoralis muscle at the height of the third rib on the anterior axillary line.
For the serratus plane block: identification of the fifth rib on the average axillary line and infusion of about 20 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of large dorsal muscle and of the anterior serratus muscle.
Opioid-free general anesthesiaProcedure or surgery
Induction with Propofol 1.5-2 mg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in Target-Controlled Infusion (TCI) of 6 mcg/ml, subsequently modified to maintain a Bispectral Index (BIS) value between 40 and 60.
Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.
In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.
General anesthesiaProcedure or surgery
Induction with Propofol 1.5-2 mg/kg; Fentanyl 1μg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in TCI of 6 mcg/ml, subsequently modified to maintain a BIS value between 40 and 60.
Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.
In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.
Postoperative analgesiaProcedure or surgery
Paracetamol 1000 mg every 8 hours for the first 24 hours, Ketorolac 30 mg in case of pain control failure (Numeric Rating Scale- NRS>4) which can be administered every 8 hours at most (max 90 mg / 24 hours), Morphine 10-20 mg IV in 24 hours as rescue analgesia.
| Study group | Role | What they receive |
|---|---|---|
| PECS + Opioid-free GA | Experimental | Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia Receives: Drug: Midazolam; Procedure: PECS; Procedure: Opioid-free general anesthesia; Procedure: Postoperative analgesia |
| GA | Active comparator | General anesthesia Receives: Drug: Midazolam; Procedure: General anesthesia; Procedure: Postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h NLR variation
Intra-patient variation of the NLR value between the pre-operative and the first post-operative day
Measured: Pre-operative and at 24 hours after the end of surgery
Secondary outcomes (5)
1h NLR variation
Intra-patient variation of the NLR value between pre-operative and 1 hour after the end of surgery, and between 1 hour after the end of surgery and 24 hours after the end of surgery
Measured: Pre-operative, 1 hour and 24 hours after the end of surgery
Opioid consumption
Consumption of intra-operative Fentanyl and post-operative Morphine hydrochloride during the first 24 hours after surgery
Measured: 24 hours
Complication
Complications related to the loco-regional anesthesia technique or to the administration of the local anesthetic. For pain evaluation, the validated Numeric Rating Scale (NRS) will be used, the score ranges from 0 to 10 with higher values corresponding to worse pain.
Measured: until hospital discharge, an average of 48 hours
Chronic pain
Chronic pain after surgery will be assessed with Brief Pain Inventory questionnaire (composed by pain severity and pain interference scores). "Douleur Neuropathique 4" (DN4) questionnaire will be used for the identification of neuropathic pain. All the scores range from 0 to 10, with 10 indicating the worst results.
Measured: 3, 6 and 12 months after surgery
Change in the levels of circulating cytokines in the post-operative period (one hour and 24 hours after surgery), compared to the baseline pre-operative values, in the two arms
differences in fold change of selected cytokines between the two arms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start31 Oct 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, open label randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Brescia, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172220
- Sponsor's protocol ID
- CRO-2019-26
- Status last verified
- Oct 2024
- First submitted
- 14 Nov 2019
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brescia F, Favero A, Segatto I, Massarut S, Zanier C, Fabiani F, Nadalini E, Morabito A, Montico M, Zucchetto A, Zanussi S, Baldassarre G, Belletti B. Impact of opioid-free general anesthesia with locoregional blocks during breast cancer surgery on systemic inflammatory response: results from a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 25:rapm-2025-106504. doi: 10.1136/rapm-2025-106504. Online ahead of print.
PubMed 40562448
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of the Neutrophil To Lymphocyte Ratio During Opioid-Free General Anesthesia Associated With Thoracic Wall Blocks Vs General Anesthesia, in Breast Cancer Quadrantectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04172220
- Acronym / sponsor ID
- CRO-2019-26
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer, PECS, Neutrophil to Lymphocyte ratio, Quadrantectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Nov 2019 (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.
The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state.
This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, open label randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| PECS + Opioid-free GA | Experimental | Drug: Midazolam, Procedure: PECS, Procedure: Opioid-free general anesthesia, Procedure: Postoperative analgesiaLoco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia |
| GA | Active comparator | Drug: Midazolam, Procedure: General anesthesia, Procedure: Postoperative analgesiaGeneral anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First diagnosis of histologically confirmed breast cancer
- Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy)
- Able to provide adequate informed consent
- With intact cognitive abilities
Key exclusion criteria (7 listed)
- Ongoing pregnancy
- In therapy or in follow-up for other cancers at the time of the study
- Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases
- History of documented allergy or previous adverse reaction to local anesthetics
- Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management
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 |
|---|---|---|
| Midazolam1-2 mg of Midazolam as premedication. | Drug | GA, PECS + Opioid-free GA |
| PECSLoco-regional anesthesia: PEC I and serratus plane block with an echoguided technique. For the PEC I: infiltration of 10 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of the pectoralis major muscle and the small pectoralis muscle at the height of the third rib on the anterior axillary line. For the serratus plane block: identification of the fifth rib on the average axillary line and infusion of about 20 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of large dorsal muscle and of the anterior serratus muscle. | Procedure or surgery | PECS + Opioid-free GA |
| Opioid-free general anesthesiaInduction with Propofol 1.5-2 mg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in Target-Controlled Infusion (TCI) of 6 mcg/ml, subsequently modified to maintain a Bispectral Index (BIS) value between 40 and 60. Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%. In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer. | Procedure or surgery | PECS + Opioid-free GA |
| General anesthesiaInduction with Propofol 1.5-2 mg/kg; Fentanyl 1μg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in TCI of 6 mcg/ml, subsequently modified to maintain a BIS value between 40 and 60. Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%. In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer. | Procedure or surgery | GA |
| Postoperative analgesiaParacetamol 1000 mg every 8 hours for the first 24 hours, Ketorolac 30 mg in case of pain control failure (Numeric Rating Scale- NRS>4) which can be administered every 8 hours at most (max 90 mg / 24 hours), Morphine 10-20 mg IV in 24 hours as rescue analgesia. | Procedure or surgery | GA, PECS + Opioid-free GA |
Primary outcome
24h NLR variation
Time frame: Pre-operative and at 24 hours after the end of surgery
Intra-patient variation of the NLR value between the pre-operative and the first post-operative day
5 secondary outcomes
1h NLR variation
Time frame: Pre-operative, 1 hour and 24 hours after the end of surgery
Opioid consumption
Time frame: 24 hours
Complication
Time frame: until hospital discharge, an average of 48 hours
Chronic pain
Time frame: 3, 6 and 12 months after surgery
Change in the levels of circulating cytokines in the post-operative period (one hour and 24 hours after surgery), compared to the baseline pre-operative values, in the two arms
Time frame: 24 hours
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 16 Oct 2024.
- Derived from this study: PubMed 40562448Brescia F, Favero A, Segatto I, Massarut S, Zanier C, Fabiani F, Nadalini E, Morabito A, Montico M, Zucchetto A, Zanussi S, Baldassarre G, Belletti B. Impact of opioid-free general anesthesia with locoregional blocks during breast cancer surgery on systemic inflammatory response: results from a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 25:rapm-2025-106504. doi: 10.1136/rapm-2025-106504. Online ahead of print.
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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.
Fabrizio Brescia, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, PECS and Opioid-free general anesthesia in people with Breast Cancer Female, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 4 inclusion and 7 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 16 Oct 2024. 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 Italy. 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?
24h NLR variation (time frame: Pre-operative and at 24 hours after the end of surgery). 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 NCT04172220, which also lists 1 linked publication.
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 16 Oct 2024.