Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

NCT04172220 | Completed

• 1 other identifier: CRO-2019-26
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Breast Cancer; PECS; Neutrophil to Lymphocyte ratio; Quadrantectomy

Outcome Measures

Primary Outcomes (1)

• 24h NLR variation

  Intra-patient variation of the NLR value between the pre-operative and the first post-operative day

  Pre-operative and at 24 hours after the end of surgery

Secondary Outcomes (5)

• 1h NLR variation

  Pre-operative, 1 hour and 24 hours after the end of surgery

• Opioid consumption

  24 hours

• Complication

  until hospital discharge, an average of 48 hours

• Chronic pain

  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

  24 hours

Study Arms (2)

PECS + Opioid-free GA

EXPERIMENTAL

Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia

Drug: Midazolam; Procedure: PECS; Procedure: Opioid-free general anesthesia; Procedure: Postoperative analgesia

GA

ACTIVE COMPARATOR

General anesthesia

Drug: Midazolam; Procedure: General anesthesia; Procedure: Postoperative analgesia

Interventions

Midazolam DRUG

1-2 mg of Midazolam as premedication.

GA; PECS + Opioid-free GA

PECS PROCEDURE

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.

PECS + Opioid-free GA

Opioid-free general anesthesia PROCEDURE

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.

PECS + Opioid-free GA

General anesthesia PROCEDURE

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.

GA

Postoperative analgesia PROCEDURE

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.

GA; PECS + Opioid-free GA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Aviano, PN, 33081, Italy

Location

Related Publications (1)

• 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.

  PMID: 40562448 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Midazolam; Anesthesia, General

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia

Study Officials

• Fabrizio Brescia, MD

  Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, open label randomised controlled trial

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: October 31, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

IT (1)