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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2022-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

NCT00635986

Fentanyl Analgesia

COMPLETED NA

Postoperative Consequences of Intraoperative NOL Titration

NCT04679818

Anesthesia; Adverse Effect

COMPLETED PHASE3

Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

NCT05861791

Postoperative Pain, Acute

COMPLETED NA

Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold

NCT00454259

Pain, Postoperative

COMPLETED PHASE4

Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries

NCT05546021

Anesthesia; Adverse Effect Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative Opioid Use Nociceptive Pain Postoperative Pain Anesthesia Allodynia Analgesics, Opioid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups of patients. Randomization into group fentanyl NOL-guided vs fentanyl standard according to randomization list for a total number of 100 patients.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Randomization into group fentanyl NOL-guided vs fentanyl standard will be done prior to the entrance in the OR, the day of the surgery.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

fentanyl NOL guided

Intervention Type DRUG

Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fentanyl NOL guided

Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NOL analgesia guided fentanyl administration

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No