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NCT Number: NCT03858621

Comparison of Postoperative Nociception Between NOL-guided and Standard Intraoperative Analgesia Based on Fentanyl

Pain is defined as an unpleasant sensory and emotional conscious experience, associated with actual or potential tissue damage. Nociception is the sympathetic response to noxious stimuli during unconsciousness. The appearance of different forms of chronic pain results from sensitization of both peripheral and central neural circuits of pain, which involves inflammatory mechanisms both at a systemic level and specifically in the peripheric and central nervous system, as observed through elevation of specific neuroinflammatory mediators, such as MCP-1, IL-1, IL-1b, and IL-10. Clinically, this sensitization expresses as hyperalgesia and allodynia, which increase postoperative pain and morbidity, but also induce permanent modifications in the nociceptive system. These effects may be ameliorated by adequately adjusting intraoperative analgesia through use of nociception/analgesia balance monitors, of which Nociception Level Index (NOL) shows convenient characteristics and promising results from previous studies.

Objectives: The goal of our study is to assess the utility of NOL index monitoring against standard care for Fentanyl-based analgesia by measuring postoperative pain, sensorial thresholds and inflammatory markers related to nociception.

Hypothesis: The use of NOL index to guide the intraoperative analgesia will produce less postoperative pain, hyperalgesia, allodynia, and neuroinflammation.

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Key information

Conditions

Pain, Postoperative Allodynia Analgesics, Opioid Anesthesia Hyperalgesia Nervous System Diseases Neurologic Manifestations Nociceptive Pain Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victor Contreras

Santiago, Santiago Metropolitan, 8420525, Chile

About this study

Methodology: In this RCT double-blinded study will invite to 100 patients aged between 18 and 50 years admitted for elective surgery that is planned to require general anesthesia, with fentanyl as the opioid of choice for intraoperative analgesia.

Each patient will be randomly allocated to one of two groups: the intervention group will be provided intraoperative analgesia guided by NOL values (n=50), and the control group will be provided standard intraoperative analgesia (n=50). To account for inter-personal variability, the NOL threshold value associated with nociceptive stimulation will be assessed on each patient at baseline condition with the Quantitative Sensory Testing (QST) and neuroinflammatory mediators MCP-1, IL-1, IL-1b, and IL-10 will be measured pre- and post-surgery in both groups. Opioid consumption and AVS will be assessed during the stay at the post-surgical care unit as a measurement of post-operative pain and will follow them until three months after surgery.

Statistical Analysis: Results will be expressed as means (±SD) or numbers (%). When indicated, 95% confidence interval (CI) will be calculated. A p-value < 0.05 will be considered statistically significant.

Differences between groups on post-surgical opioid consumption, Δz-score of QST measurements, and serum biomarkers level will be analyzed with Student's T-test for unpaired samples. For analysis purposes, VAS scores will be grouped into three distinct categories: Mild (0-3), Moderate (4-6) and Severe (7-10) pain. Differences between groups will be analyzed with Chi-square test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-II
  • Elective abdominal surgery without a neuraxial block.
  • Over 2 horas.
  • Body Mass Index 18 - 30 kg/m2

Exclusion criteria

  • Cardiac surgery
  • Cardiopathy
  • Arrhythmia or use of pacemakers.
  • Chronic Kidney disease (Plasma Crea >1 mg/dL).
  • Allergic to drugs of this study.
  • Opioids or Non-inflammatory drugs over 5 days for two weeks before surgery.
  • Neuropathies and dysautonomias.
  • Beta-blockers and other drugs that act at the level of the sympathetic system the month prior to surgery.
  • Chemotherapy.

Treatment and study plan

fentanyl NOL guided

Drug

Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.

Other names: NOL analgesia guided fentanyl administration

Primary outcomes

  1. Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group.

    Time frame: Intra-operative

    Total consumption of fentanyl in mcg.

  2. Consumption of opioid in the early postoperative in the NOL-guided group compared to the standard group.

    Time frame: Postoperative Unit (2 hours)

    Total consumption of morphine in mg.

Secondary outcomes

  1. Pain measured by Visual Analog Scale (VAS) in the NOL-guided group compared to the standard group.

    Time frame: Postoperative Unit (Every 30 minutes per 2 hours)

    Visual Analog Scale 0 to 10. 0 = no pain. 10 = worse pain Values to find out is less than 5-6

  2. Sensorial thresholds in the NOL-guided group compared to the standard group.

    Time frame: Postoperative Unit (2 hours)

    QST (Quantitative Sensory Testing) is a valuable method for diagnosing peripheral nervous system disorders.

    • Thermal Testing
    • Mechanical test threshold
    • Mechanical pain threshold
    • Wind-up phenomenon
    • Vibration detection threshold
    • Pressure pain threshold

  3. Pain Management Satisfaction in the NOL-guided group compared to the standard group.

    Time frame: Postoperative Unit (2 hours)

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question

  4. Pain Management Satisfaction in the NOL-guided group compared to the standard group.

    Time frame: Postoperative (6 hours)

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question

  5. Pain Management Satisfaction in the NOL-guided group compared to the standard group.

    Time frame: Postoperative (12 hours)

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question

  6. Inflammatory markers in the NOL-guided group compared to the standard group.

    Time frame: Postoperative (0 hours)

    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  7. Inflammatory markers in the NOL-guided group compared to the standard group.

    Time frame: Postoperative (6 hours)

    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  8. Inflammatory markers in the NOL-guided group compared to the standard group.

    Time frame: Postoperative (12 hours)

    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  9. Persistent pain at three months in the NOL-guided group compared to the standard group.

    Time frame: 3 months after surgery

    Brief Pain Inventory by telephone call

Sponsors and collaborators

Lead sponsor

Victor Contreras, MSN

Other

Registry information

Official study title

Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia

Acronym: NOLFentanyl

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2019
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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