An interventional study of fentanyl NOL guided in Pain, Postoperative, Opioid Use and Nociceptive Pain, sponsored by Victor Contreras, MSN. Completed at 1 site in Chile. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Victor Contreras, MSN · Not applicable, Interventional, and Prevention
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Among 27 studies in Pain, Postoperative with a site in Chile — 6 open to participants now, 6 under way, none of them phase 3. Pain, Postoperative · Chile.
Among the 27 studies in Pain, Postoperative with a site in Chile, this one is the 3rd largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2019, is one of 16 with no phase, and was the 11th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →6 of the 27 studies in Pain, Postoperative with a site in Chile are open now. Recruiting first, the newest first:
Universidad de los Andes, Chile · Sites in Chile
Ages 18–80
Clínica Dávila · Sites in Chile
Ages 18+
Pontificia Universidad Catolica de Chile · Sites in Chile
Ages 18+
University of Chile · Sites in Chile
Ages 18–80
Pontificia Universidad Catolica de Chile · Sites in Chile
Ages 18+
A study can be open while its sites in Chile have not opened yet or have stopped. Only those recruiting at a site in Chile →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 75 across 4,825 interventional studies indexed under Pain, Postoperative.
Median enrollment 60 across the 23 interventional studies, 44 across the 4 observational. Of the 19 that completed or were terminated, 0 (0%) have results posted.
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None of the 27 has an industry lead sponsor. The 10 most frequent:
Victor Contreras, MSN is the lead sponsor of 3 studies on the registry; none are open to participants now.
Victor Contreras, MSN has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
3 of the studies in Pain, Postoperative with a site in Chile that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07330947Pontificia Universidad Catolica de ChileIncidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery | 2026-12-01 |
| NCT07733128Clínica DávilaAnalgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery | 2027-03 |
| NCT07334288Universidad de los Andes, ChileRetrolaminar Analgesia for LuMbar Surgery | 2027-06-01 |
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Among the 27 studies in Pain, Postoperative with a site in Chile, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group.
Total consumption of fentanyl in mcg.
Time frame: 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.
Time frame: Postoperative Unit (2 hours)
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
Time frame: Postoperative Unit (Every 30 minutes per 2 hours)
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. 1. Thermal Testing 2. Mechanical test threshold 3. Mechanical pain threshold 4. Wind-up phenomenon 5. Vibration detection threshold 6. Pressure pain threshold
Time frame: Postoperative Unit (2 hours)
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
Time frame: Postoperative Unit (2 hours)
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
Time frame: Postoperative (6 hours)
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
Time frame: Postoperative (12 hours)
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)
Time frame: Postoperative (0 hours)
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)
Time frame: Postoperative (6 hours)
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)
Time frame: Postoperative (12 hours)
Persistent pain at three months in the NOL-guided group compared to the standard group.
Brief Pain Inventory by telephone call
Time frame: 3 months after surgery
Plan to share: No
Ran from Mar 2019 to primary completion in Feb 2022, 35 months.
Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 35 months is above that.
Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Victor Contreras, MSN