Pain, PostoperativeNOLFentanylNCT03858621
Comparison of Postoperative Nociception Between NOL-guided and Standard Intraoperative Analgesia Based on Fentanyl
A study testing fentanyl NOL guided in people with Pain, Postoperative and Opioid Use, run by Victor Contreras, MSN at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Nociceptive Pain
- What is being tested?
- fentanyl NOL guided
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 15 Mar 2019to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II
- Elective abdominal surgery without a neuraxial block.
- Over 2 horas.
- Body Mass Index 18 - 30 kg/m2
Who cannot join
- 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.
Show all 9Show fewer
- Neuropathies and dysautonomias.
- Beta-blockers and other drugs that act at the level of the sympathetic system the month prior to surgery.
- Chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia
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.
Read the detailed description
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.
- Conditions
- Pain, Postoperative, Opioid Use, Nociceptive Pain, Postoperative Pain, Anesthesia, Allodynia
- Being tested
- fentanyl NOL guided
- Keywords
- pain, Postoperative Pain, fentanyl, Nociceptive monitoring index
- Medical subject headings
- Pain, Postoperative, Nociceptive Pain, Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl NOL guidedDrug
Also called NOL analgesia guided fentanyl administration
Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group.
Total consumption of fentanyl in mcg.
Measured: 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.
Measured: Postoperative Unit (2 hours)
Secondary outcomes (9)
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
Measured: 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.
- Thermal Testing
- Mechanical test threshold
- Mechanical pain threshold
- Wind-up phenomenon
- Vibration detection threshold
- Pressure pain threshold
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Postoperative (12 hours)
Persistent pain at three months in the NOL-guided group compared to the standard group.
Brief Pain Inventory by telephone call
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start15 Mar 2019
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of patients. Randomization into group fentanyl NOL-guided vs fentanyl standard according to randomization list for a total number of 100 patients.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Contreras, MSN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victor Contreras, MSN, Pontificia Universidad Catolica de Chile
- Investigators
- VICTOR CONTRERAS, MSN, Study director, Research Profesor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858621
- Sponsor's protocol ID
- 180522017
- Other IDs
- FONDECYT Iniciacion
- Acronym
- NOLFentanyl
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2019
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21620344Baliki 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.
PubMed 26247858Katz 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.
PubMed 19402781Argoff 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.
PubMed 23945010
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Nociception Outcomes Between NOL - Guided and Standard Intraoperative Analgesia Based on Fentanyl in Patients Undergoing Elective Surgery With General Anesthesia
- ClinicalTrials.gov ID
- NCT03858621
- Acronym / sponsor ID
- NOLFentanyl / 180522017
- Conditions
- Pain, Postoperative, Opioid Use, Nociceptive Pain, Postoperative Pain, Anesthesia, Allodynia
- Keywords
- pain, Postoperative Pain, fentanyl, Nociceptive monitoring index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Victor Contreras, MSNUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of patients. Randomization into group fentanyl NOL-guided vs fentanyl standard according to randomization list for a total number of 100 patients.
| Arm | Type | Receives |
|---|---|---|
| fentanyl NOL guided | Experimental | Drug: fentanyl NOL guidedA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II
- Elective abdominal surgery without a neuraxial block.
- Over 2 horas.
- Body Mass Index 18 - 30 kg/m2
Key exclusion criteria (9 listed)
- Cardiac surgery
- Cardiopathy
- Arrhythmia or use of pacemakers.
- Chronic Kidney disease (Plasma Crea >1 mg/dL).
- Allergic to drugs of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl NOL guidedAlso: NOL analgesia guided fentanyl administrationIntervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery. | Drug | fentanyl NOL guided |
Primary outcome
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.
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.
9 secondary outcomes
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)
Sensorial thresholds in the NOL-guided group compared to the standard group.
Time frame: Postoperative Unit (2 hours)
Pain Management Satisfaction in the NOL-guided group compared to the standard group.
Time frame: Postoperative Unit (2 hours)
Pain Management Satisfaction in the NOL-guided group compared to the standard group.
Time frame: Postoperative (6 hours)
Pain Management Satisfaction in the NOL-guided group compared to the standard group.
Time frame: Postoperative (12 hours)
Inflammatory markers in the NOL-guided group compared to the standard group.
Time frame: Postoperative (0 hours)
Inflammatory markers in the NOL-guided group compared to the standard group.
Time frame: Postoperative (6 hours)
Inflammatory markers in the NOL-guided group compared to the standard group.
Time frame: Postoperative (12 hours)
Persistent pain at three months in the NOL-guided group compared to the standard group.
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Results publication: PubMed 21620344Gandhi 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.
- Results publication: PubMed 26247858Baliki 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.
- Results publication: PubMed 19402781Katz 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.
- Results publication: PubMed 23945010Argoff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VICTOR CONTRERAS, MSN study director
Research Profesor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl NOL guided in people with Pain, Postoperative and Opioid Use, run by Victor Contreras, MSN at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of IV fentanyl intra-operative in the NOL-guided group compared to the standard group. (time frame: Intra-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858621, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.