Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 761 for:    region | Chile

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03858621
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Victor Contreras, MSN, Pontificia Universidad Catolica de Chile

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Opioid Use Nociceptive Pain Postoperative Pain Anesthesia Allodynia Analgesics, Opioid Drug: fentanyl NOL guided Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description: Randomization into group fentanyl NOL-guided vs fentanyl standard will be done prior to the entrance in the OR, the day of the surgery.
Primary Purpose: Prevention
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
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 a predeterminate NOL index + heart rate + mean arterial blood pressure variations.
Drug: fentanyl NOL guided
Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.
Other Name: NOL analgesia guided fentanyl administration

No Intervention: fentanyl standard analgesia
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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) ]
    Visual Analog Scale 0 to 10. 0 = no pain. 10 = worse pain Values to find out is less than 5-6

  2. Sensorial thresholds in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative Unit (2 hours) ]

    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

  3. Pain Management Satisfaction in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative Unit (2 hours) ]

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question


  4. Pain Management Satisfaction in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative (6 hours) ]

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question


  5. Pain Management Satisfaction in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative (12 hours) ]

    Pain Management Satisfaction Scale

    1 to 5. 1 = Not satisfied at all. 5 = Completly satisfied One question


  6. Inflammatory markers in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative (0 hours) ]
    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  7. Inflammatory markers in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative (6 hours) ]
    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  8. Inflammatory markers in the NOL-guided group compared to the standard group. [ Time Frame: Postoperative (12 hours) ]
    Concentration in plasma of: MCP1 (pg/mL) , IL6 (pg/mL) , IL1b (pg/mL), IL10 (pg/mL)

  9. Persistent pain at three months in the NOL-guided group compared to the standard group. [ Time Frame: 3 months after surgery ]
    Brief Pain Inventory by telephone call



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858621


Contacts
Layout table for location contacts
Contact: VICTOR E CONTRERAS, MSN +56981895232 vecontre@uc.cl
Contact: MAURICIO IBACACHE, PhD +56223543270 mibacach@med.puc.cl

Locations
Layout table for location information
Chile
Victor Contreras Recruiting
Santiago, Región Metropolitana, Chile, 8420525
Contact: VICTOR CONTRERAS, MSN    56223549217    vecontre@uc.cl   
Contact: MAURICIO IBACACHE, PhD    56223543270    mibacach@med.puc.cl   
Principal Investigator: MAURICIO IBACACHE, PhD         
Sponsors and Collaborators
Victor Contreras, MSN
Investigators
Layout table for investigator information
Study Director: VICTOR CONTRERAS, MSN Research Profesor

Publications of Results:
Layout table for additonal information
Responsible Party: Victor Contreras, MSN, Co-Investigador, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03858621     History of Changes
Other Study ID Numbers: 180522017
FONDECYT Iniciacion ( Other Grant/Funding Number: 11180674 )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Victor Contreras, MSN, Pontificia Universidad Catolica de Chile:
pain
Postoperative Pain
fentanyl
Nociceptive monitoring index

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Hyperalgesia
Nociceptive Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics