Anesthesia; Adverse Effect, Breast Cancer
Conditions
Keywords
nociception level monitor
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURENOL monitor
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.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peroperative Remifentanil consumption | during the surgery | ( peroperative, mg) |
| Peroperative Morphine consumption | during the surgery | (peroperative, mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eligible time to discharge | immediately after the surgery | Time in the post anaesthesia care unit based on a post anaesthesia care score scheme derived from objective vital parameters (Minutes) |
| Length of hospital stay | From admission to discharge, up to 72 hours | Hours |
| Incidence of post-operative nausea and vomiting | immediately after the surgery | Number of patients with post-operative nausea and vomiting |
| Postoperative Maximum pain score | immediately after the 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. |
| Persistent neuropathic pain after breast cancer surgery | up to 3 months after 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. |
| Length of time in recovery room | immediately after surgery | minutes |
| Requirement for additional antiemetic drugs | immediately after the surgery | Number 1-3 |
| Post-operative opioid consumption | immediately after the surgery | Morphine, mg |
Countries
Denmark
Outcome results
None listed