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NCT Number: NCT05873894

Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia

Chronic pain is an undesirable condition that impacts predominantly quality of life at all levels. Chronic pain might occur in healthy young patients when acute postoperative pain is undertreated and persists in time. There are some indexes in the market to evaluate pain, but they assess mainly parasympathetic activity. Hence, it´s a measure of the physiological response to pain, which is still a not well-defined concept. Patients under General Anesthesia might be experimenting unnoticed pain as there is no direct standard method to measure it in clinical practice. This study aims to detect brain oscillatory activity in the intraoperative setting in four situations; awake-no pain, awake-pain, sleep-no pain, and sleep-pain. Pain can be assessed by studying the local and global dynamics of brain activity. A promising upcoming measure of pain could be implemented in clinical practice to detect and treat pain.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHGUV, Valencia, Spain

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About this study

This is a pilot study of the presence of neural oscillations during acute pain while awake and in the anesthetized patient with neurophysiological monitoring during a neurosurgery surgical intervention analyzed by electroencephalography.

After the patient's consent, the electroencephalogram is placed in the awake patient and a small painful stimulus is performed based on the channeling of a second venous access. In turn, a recording of the EEG waves is made in order to identify similar neuronal waves during the surgical procedure once the patient is under general anesthesia.

The reason for this intervention is to have a baseline record of each patient without interfering with the oscillations of the different drugs used during total intravenous anesthesia used in these procedures. Normally, after general anesthesia, between 3 and 6 electrodes would be placed on the scalp and 10 electrodes would be placed to carry out this work.

After the intervention, a telephone survey will be carried out on postoperative pain at 3 months and a year.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients that undergo schedule neurosurgery with neurophysiological monitorisation.
  • American Society of Anaesthesiologist physical status (ASA) I-IV.

Exclusion criteria

  • Pregnancy
  • Obstructive hydrocephaly with or with a derivative catheter.
  • Patients with neurostimulator
  • Emergency surgery.

Treatment and study plan

EEG

Device

EEG recordings and analysis. Sensory evoked potentials analysis Motor evoked potentials studies

Primary outcomes

  1. Oscillations related to pain in the EEG

    Time frame: since start of surgery until the end

    The main objective is the characterization and evaluation of the neural oscillations in the EEG that occur in the anesthetized patient when acute intraoperative pain occurs during monitoring by neurophysiology in neurosurgery.

    The current procedure includes patient monitoring with neurophysiology electrodes at muscle level and EEG for proper mapping of the functions to be explored when the patient is under the effects of general anesthesia.

    To carry out this work, it would be necessary to monitor the EEG with the patient awake, since it is intended to look for the characteristic neural oscillations at the moment in which the second peripheral venous line is cannulated.

Secondary outcomes

  1. Incidence of Chronic pain

    Time frame: after surgery until 1 year post surgery

    • Develop an objective scale of pain in the patient under general anesthesia.
    • Evaluate the degree of pain 3 months after surgery using the visual analogue scale in the operated patients or/and Pain Detect Questionnarie .

  2. opiod consumption

    Time frame: during surgery until 1 year post surgery

    During the intraoperative phase we will base ourselves on the equivalence between the use of intravenous fentanyl or oxycodone and intravenous morphine. For the subsequent evaluation of opioid consumption one year after surgery, we will base ourselves on the conversion tables to oral morphine.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina S Romero, PhD

CONTACT

[email protected]

+34963187554

Paula Solis, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Valencia

Other

Registry information

Official study title

Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia: Characterisation of EEG Patterns Secondary to Pain

Acronym: EEGpain

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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