Clinical trial NCT05546021: Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries
Official title: Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia; Adverse Effect
Breast Cancer
Keywords: nociception level monitor
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peroperative Remifentanil consumption
timeFrame: during the surgery
measure: Peroperative Morphine consumption
timeFrame: during the surgery
Secondary outcomes:
measure: Postoperative Maximum pain score
timeFrame: immediately after the surgery
measure: Post-operative opioid consumption
timeFrame: immediately after the surgery
measure: Eligible time to discharge
timeFrame: immediately after the surgery
measure: Length of hospital stay
timeFrame: From admission to discharge, up to 72 hours
measure: Incidence of post-operative nausea and vomiting
timeFrame: immediately after the surgery
measure: Requirement for additional antiemetic drugs
timeFrame: immediately after the surgery
measure: Persistent neuropathic pain after breast cancer surgery
timeFrame: up to 3 months after surgery
measure: Length of time in recovery room
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
affiliation: University of Hospital of Southern Denmark - Aabenraa
name: Rajesh Prabhakar Bhavsar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.