Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Drug: Midazolam; Procedure: General anesthesia; Procedure: PECS; Procedure: Opioid-free general anesthesia; Procedure: Postoperative analgesia

• Registration Number: NCT04172220
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Primary Completion: 2021-11-01
• Study Completion: 2022-11-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS + Opioid-free GA	Opioid-free general anesthesia	Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
PECS + Opioid-free GA	Postoperative analgesia	Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
GA	General anesthesia	General anesthesia
GA	Postoperative analgesia	General anesthesia
PECS + Opioid-free GA	PECS	Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
PECS + Opioid-free GA	Midazolam	Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
GA	Midazolam	General anesthesia

Primary Outcome Measures

Name	Time	Method
24h NLR variation	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

Secondary Outcome Measures

Name	Time	Method
1h NLR variation	Pre-operative, 1 hour and 24 hours after the end of surgery	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	24 hours	Consumption of intra-operative Fentanyl and post-operative Morphine hydrochloride during the first 24 hours after surgery
Complication	until hospital discharge, an average of 48 hours	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	3, 6 and 12 months after surgery	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.
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	differences in fold change of selected cytokines between the two arms

Trial Locations

Locations (1)

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS; 🇮🇹 Aviano, PN, Italy