Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries

NCT05546021 | Completed

• 1 other identifier: SHS-An-1-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery.
2. 2.Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks.
3. 3.Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.

Conditions

Anesthesia; Adverse Effect; Breast Cancer

Keywords

nociception level monitor

Outcome Measures

Primary Outcomes (2)

• Peroperative Remifentanil consumption

  ( peroperative, mg)

  during the surgery

• Peroperative Morphine consumption

  (peroperative, mg)

  during the surgery

Secondary Outcomes (8)

• Postoperative Maximum pain score

  immediately after the surgery

• Post-operative opioid consumption

  immediately after the surgery

• Eligible time to discharge

  immediately after the surgery

• Length of hospital stay

  From admission to discharge, up to 72 hours

• Incidence of post-operative nausea and vomiting

  immediately after the surgery

Study Arms (2)

NOL monitor

ACTIVE COMPARATOR

Patients will receive opioids as per the guidance of a nociception level monitor (NOL)

Procedure: NOL monitor

Standard care

NO INTERVENTION

Patients will be treated as per the department´s standard protocol.

Interventions

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.

NOL monitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection

You may not qualify if:

• Inability to give consent,
• atrial fibrillation,
• local anesthetic allergy,
• lumpectomy converted to Mastectomy.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (4)

• 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.

  PMID: 27171828 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.

  PMID: 26154185 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.

  PMID: 29756750 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.

  PMID: 39768803 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rajesh Prabhakar Bhavsar

  University of Hospital of Southern Denmark - Aabenraa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)