Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

NCT ID: NCT04172220

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

PECS + Opioid-free GA

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

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

1-2 mg of Midazolam as premedication.

PECS

Intervention Type: 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.

Opioid-free general anesthesia

Intervention Type: 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.

Postoperative analgesia

Intervention Type: 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

General anesthesia

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

1-2 mg of Midazolam as premedication.

General anesthesia

Intervention Type: 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.

Postoperative analgesia

Intervention Type: 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.

Interventions

Midazolam

1-2 mg of Midazolam as premedication.

Intervention Type: DRUG

PECS

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.

Intervention Type: PROCEDURE

Opioid-free general anesthesia

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.

Intervention Type: PROCEDURE

General anesthesia

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.

Intervention Type: PROCEDURE

Postoperative analgesia

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrizio Brescia, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Locations

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Aviano, PN, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40562448 (View on PubMed)

Other Identifiers

CRO-2019-26

Identifier Type: -

Identifier Source: org_study_id