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

NCT03858621 | Completed DMC

• 2 other identifiers: 180522017FONDECYT Iniciacion
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Opioid Use; Nociceptive Pain; Postoperative Pain; Anesthesia; Allodynia; Analgesics, Opioid

Keywords

pain; Postoperative Pain; fentanyl; Nociceptive monitoring index

Outcome Measures

Primary Outcomes (2)

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

  Total consumption of fentanyl in mcg.

  Intra-operative

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

  Total consumption of morphine in mg.

  Postoperative Unit (2 hours)

Secondary Outcomes (9)

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

  Postoperative Unit (Every 30 minutes per 2 hours)

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

  Postoperative Unit (2 hours)

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

  Postoperative Unit (2 hours)

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

  Postoperative (6 hours)

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

  Postoperative (12 hours)

Study Arms (2)

fentanyl NOL guided

EXPERIMENTAL

A bolus of 2 mcg/kg IV Fentanyl will be given at the induction of the anesthesia. A bolus of 0,5 - 1 mcg/kg IV Fentanyl will be given at the time of incision and during surgery following a predeterminate NOL index + heart rate + mean arterial blood pressure variations.

Drug: fentanyl NOL guided

fentanyl standard analgesia

NO INTERVENTION

A bolus of 2 mcg/kg IV Fentanyl will be given at the induction of the anesthesia. A bolus of 0,5 - 1 mcg/kg IV Fentanyl will be given at the time of incision and during surgery following the heart rate and mean arterial blood pressure variations.

Interventions

fentanyl NOL guided DRUG

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

Also known as: NOL analgesia guided fentanyl administration

fentanyl NOL guided

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victor Contreras, MSN: lead

Study Sites (1)

Victor Contreras

Santiago, Santiago Metropolitan, 8420525, Chile

Location

Related Publications (4)

• Gandhi K, Heitz JW, Viscusi ER. Challenges in acute pain management. Anesthesiol Clin. 2011 Jun;29(2):291-309. doi: 10.1016/j.anclin.2011.04.009.

  PMID: 21620344 RESULT

• Baliki MN, Apkarian AV. Nociception, Pain, Negative Moods, and Behavior Selection. Neuron. 2015 Aug 5;87(3):474-91. doi: 10.1016/j.neuron.2015.06.005.

  PMID: 26247858 RESULT

• Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.

  PMID: 19402781 RESULT

• Argoff CE. Recent management advances in acute postoperative pain. Pain Pract. 2014 Jun;14(5):477-87. doi: 10.1111/papr.12108. Epub 2013 Aug 15.

  PMID: 23945010 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Nociceptive Pain; Hyperalgesia; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• VICTOR CONTRERAS, MSN

  Research Profesor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization into group fentanyl NOL-guided vs fentanyl standard will be done prior to the entrance in the OR, the day of the surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigador

Model Details: 2 groups of patients. Randomization into group fentanyl NOL-guided vs fentanyl standard according to randomization list for a total number of 100 patients.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 15, 2019
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)