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Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

Primary Purpose

Breast Cancer Female

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Midazolam
PECS
Opioid-free general anesthesia
General anesthesia
Postoperative analgesia
Sponsored by
Centro di Riferimento Oncologico - Aviano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer Female focused on measuring Breast Cancer, PECS, Neutrophil to Lymphocyte ratio, Quadrantectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Centro di Riferimento Oncologico di Aviano (CRO), IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PECS + Opioid-free GA

GA

Arm Description

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

General anesthesia

Outcomes

Primary Outcome Measures

24h NLR variation
Intra-patient variation of the NLR value between the pre-operative and the first post-operative day

Secondary Outcome Measures

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
Opioid consumption
Consumption of intra-operative Fentanyl and post-operative Morphine hydrochloride during the first 24 hours after surgery
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.
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.

Full Information

First Posted
November 14, 2019
Last Updated
November 20, 2019
Sponsor
Centro di Riferimento Oncologico - Aviano
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1. Study Identification

Unique Protocol Identification Number
NCT04172220
Brief Title
Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro di Riferimento Oncologico - Aviano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Breast Cancer, PECS, Neutrophil to Lymphocyte ratio, Quadrantectomy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, open label randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECS + Opioid-free GA
Arm Type
Experimental
Arm Description
Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
Arm Title
GA
Arm Type
Active Comparator
Arm Description
General anesthesia
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
1-2 mg of Midazolam as premedication.
Intervention Type
Procedure
Intervention Name(s)
PECS
Intervention Description
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
Intervention Name(s)
Opioid-free general anesthesia
Intervention Description
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
Intervention Name(s)
General anesthesia
Intervention Description
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
Intervention Name(s)
Postoperative analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
24h NLR variation
Description
Intra-patient variation of the NLR value between the pre-operative and the first post-operative day
Time Frame
Pre-operative and at 24 hours after the end of surgery
Secondary Outcome Measure Information:
Title
1h NLR variation
Description
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
Time Frame
Pre-operative, 1 hour and 24 hours after the end of surgery
Title
Opioid consumption
Description
Consumption of intra-operative Fentanyl and post-operative Morphine hydrochloride during the first 24 hours after surgery
Time Frame
24 hours
Title
Complication
Description
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.
Time Frame
until hospital discharge, an average of 48 hours
Title
Chronic pain
Description
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.
Time Frame
3, 6 and 12 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrizio Brescia, MD
Phone
+39 0434659165
Email
fabrizio.brescia@cro.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Brescia, MD
Organizational Affiliation
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Brescia, MD
Email
fabrizio.brescia@cro.it

12. IPD Sharing Statement

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Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

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