Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

  • STATUS
    Recruiting
  • End date
    Nov 23, 2021
  • participants needed
    68
  • sponsor
    Centro di Riferimento Oncologico - Aviano
Updated on 23 January 2021
opioid
cancer
breast surgery
breast cancer
midazolam
axillary lymph node dissection

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.

Details
Condition Breast Cancer Female
Treatment General anesthesia, Midazolam, PECS, Opioid-free general anesthesia, Postoperative analgesia, Postoperative analgesia
Clinical Study IdentifierNCT04172220
SponsorCentro di Riferimento Oncologico - Aviano
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer Female?
Do you have any of these conditions: Do you have Breast Cancer Female??
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)
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