Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries

Study Overview
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Brief Summary
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To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia. Hypothesis: NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks. Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.

Detailed Description
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Optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. Despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. This may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. In that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. Recently, a nociception level monitor (NOL) based on an advanced software algorithm was developed using multiple physiological parameters. It offers an objective number (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. With the availability of NOL monitors, a meticulous adjustment in the administration of opioids became a possibility. Therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.

Official Title
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Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay

Conditions
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Anesthesia; Adverse Effect, Breast Cancer

Intervention / Treatment
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* Procedure: NOL monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection Exclusion Criteria: Inability to give consent, atrial fibrillation, local anesthetic allergy, lumpectomy converted to Mastectomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NOL monitor<br>Patients will receive opioids as per the guidance of a nociception level monitor (NOL) | Procedure: NOL monitor<br>* NOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to continuous monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's nociceptive state and analgesic effect, helping to optimize the administration of systemic and/or regional analgesics and avoiding overdose or underuse of these drugs. The nociception level is a multiparameter monitor that combines information from the finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation, heart rate, heart rate variability, and their time derivatives into one index ranging from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation). The nociception level is a composite score derived from a set of physiologic variables (i.e., peripheral effectors of the autonomous nervous system): heart rate, heart rate variability, the amplitude of the photoplethysmogram, skin conductance, skin conductance variability, and the time derivatives of these variables.<br>|
| No Intervention: Standard care<br>Patients will be treated as per the department´s standard protocol. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative Remifentanil consumption | ( peroperative, mg) | during the surgery | 
| Peroperative Morphine consumption | (peroperative, mg) | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Maximum pain score | measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. | immediately after the surgery | 
| Post-operative opioid consumption | Morphine, mg | immediately after the surgery | 
| Eligible time to discharge | Time in the post anaesthesia care unit based on a post anaesthesia care score scheme derived from objective vital parameters (Minutes) | immediately after the surgery | 
| Length of hospital stay | Hours | From admission to discharge, up to 72 hours | 
| Incidence of post-operative nausea and vomiting | Number of patients with post-operative nausea and vomiting | immediately after the surgery | 
| Requirement for additional antiemetic drugs | Number 1-3 | immediately after the surgery | 
| Persistent neuropathic pain after breast cancer surgery | Number of patients experiencing pain due to breast cancer surgery measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. | up to 3 months after surgery | 
| Length of time in recovery room | minutes | immediately after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nociception level monitor