Postoperative Pain Clinical Trial
— NOLFentanylOfficial title:
Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia
Verified date | March 2022 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 23, 2022 |
Est. primary completion date | February 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Victor Contreras | Santiago | Región Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Victor Contreras, MSN |
Chile,
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group. | Total consumption of fentanyl in mcg. | Intra-operative | |
Primary | 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 | Pain measured by Visual Analog Scale (VAS) in the NOL-guided group compared to the standard group. | Visual Analog Scale 0 to 10. 0 = no pain. 10 = worse pain Values to find out is less than 5-6 | Postoperative Unit (Every 30 minutes per 2 hours) | |
Secondary | Sensorial thresholds in the NOL-guided group compared to the standard group. | 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 |
Postoperative Unit (2 hours) | |
Secondary | Pain Management Satisfaction in the NOL-guided group compared to the standard group. | Pain Management Satisfaction Scale
1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question |
Postoperative Unit (2 hours) | |
Secondary | Pain Management Satisfaction in the NOL-guided group compared to the standard group. | Pain Management Satisfaction Scale
1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question |
Postoperative (6 hours) | |
Secondary | Pain Management Satisfaction in the NOL-guided group compared to the standard group. | Pain Management Satisfaction Scale
1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question |
Postoperative (12 hours) | |
Secondary | Inflammatory markers in the NOL-guided group compared to the standard group. | Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL) | Postoperative (0 hours) | |
Secondary | Inflammatory markers in the NOL-guided group compared to the standard group. | Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL) | Postoperative (6 hours) | |
Secondary | Inflammatory markers in the NOL-guided group compared to the standard group. | Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL) | Postoperative (12 hours) | |
Secondary | Persistent pain at three months in the NOL-guided group compared to the standard group. | Brief Pain Inventory by telephone call | 3 months after surgery |
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