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

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Victor Contreras, MSN
• Treatments: Fentanyl

Criteria

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.