Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries
July 28, 2025 updated by: University of Southern Denmark
Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aabenraa, Denmark, 6200
- Sygehus Soenderjylland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: NOL monitor
Patients will receive opioids as per the guidance of a nociception level monitor (NOL)
|
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. |
|
No Intervention: Standard care
Patients will be treated as per the department´s standard protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peroperative Remifentanil consumption
Time Frame: during the surgery
|
( peroperative, mg)
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during the surgery
|
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Peroperative Morphine consumption
Time Frame: during the surgery
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(peroperative, mg)
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during the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Maximum pain score
Time Frame: 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.
|
immediately after the surgery
|
|
Post-operative opioid consumption
Time Frame: immediately after the surgery
|
Morphine, mg
|
immediately after the surgery
|
|
Eligible time to discharge
Time Frame: 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)
|
immediately after the surgery
|
|
Length of hospital stay
Time Frame: From admission to discharge, up to 72 hours
|
Hours
|
From admission to discharge, up to 72 hours
|
|
Incidence of post-operative nausea and vomiting
Time Frame: immediately after the surgery
|
Number of patients with post-operative nausea and vomiting
|
immediately after the surgery
|
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Requirement for additional antiemetic drugs
Time Frame: immediately after the surgery
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Number 1-3
|
immediately after the surgery
|
|
Persistent neuropathic pain after breast cancer surgery
Time Frame: 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.
|
up to 3 months after surgery
|
|
Length of time in recovery room
Time Frame: immediately after surgery
|
minutes
|
immediately after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rajesh Prabhakar Bhavsar, University of Hospital of Southern Denmark - Aabenraa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
January 31, 2024
Study Completion (Actual)
February 28, 2024
Study Registration Dates
First Submitted
August 30, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 19, 2022
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 28, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHS-An-1-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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