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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Anesthesia; Adverse Effect
• Interventions: Procedure: NOL monitor

• Registration Number: NCT05546021
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-19
• Study Start: 2023-09-01
• Primary Completion: 2024-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Peroperative Remifentanil consumption	during the surgery	( peroperative, mg)
Peroperative Morphine consumption	during the surgery	(peroperative, mg)

Secondary Outcome Measures

Name	Time	Method
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.
Post-operative opioid consumption	immediately after the surgery	Morphine, mg
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
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.
Requirement for additional antiemetic drugs	immediately after the surgery	Number 1-3
Length of time in recovery room	immediately after surgery	minutes

Trial Locations

Locations (1)

Sygehus Soenderjylland; 🇩🇰 Aabenraa, Denmark