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: 1. NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery. 2. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks. 3. Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
Sygehus Soenderjylland
Aabenraa, Denmark
Peroperative Remifentanil consumption
( peroperative, mg)
Time frame: during the surgery
Peroperative Morphine consumption
(peroperative, mg)
Time frame: during the surgery
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.
Time frame: immediately after the surgery
Post-operative opioid consumption
Morphine, mg
Time frame: 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)
Time frame: immediately after the surgery
Length of hospital stay
Hours
Time frame: From admission to discharge, up to 72 hours
Incidence of post-operative nausea and vomiting
Number of patients with post-operative nausea and vomiting
Time frame: immediately after the surgery
Requirement for additional antiemetic drugs
Number 1-3
Time frame: 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.
Time frame: up to 3 months after surgery
Length of time in recovery room
minutes
Time frame: immediately after surgery
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