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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOL monitor | Active Comparator | Patients will receive opioids as per the guidance of a nociception level monitor (NOL) |
|
| Standard care | No Intervention | Patients will be treated as per the department´s standard protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOL monitor | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peroperative Remifentanil consumption | ( peroperative, mg) | during the surgery |
| Peroperative Morphine consumption | (peroperative, mg) | during the surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Prabhakar Bhavsar | University of Hospital of Southern Denmark - Aabenraa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Soenderjylland | Aabenraa | 6200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27171828 | Background | Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130. | |
| 26154185 | Background | Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
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 |
| 29756750 | Background | Stockle PA, Julien M, Issa R, Decary E, Brulotte V, Drolet P, Henri M, Poirier M, Latulippe JF, Dorais M, Verdonck O, Fortier LP, Richebe P. Validation of the PMD100 and its NOL Index to detect nociception at different infusion regimen of remifentanil in patients under general anesthesia. Minerva Anestesiol. 2018 Oct;84(10):1160-1168. doi: 10.23736/S0375-9393.18.12720-9. Epub 2018 May 14. |
| 39768803 | Background | Malachauskiene L, Bhavsar R, Bakke S, Keller J, Bhavsar S, Luy AM, Strom T. Influence of Nociception Level Monitor (NOL)-Guided Analgesic Delivery on Perioperative Course in Breast Surgeries: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Nov 22;60(12):1921. doi: 10.3390/medicina60121921. |
| D017437 |
| Skin and Connective Tissue Diseases |