Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia (EEGpain)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Device: EEG

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Carolina S Romero, PhD; Phone Number: +34963187554; Email: romero_carolinasol@gva.es
• Study Contact Backup: Name: Paula Solis, MD; Email: paulasolisalbamonte@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46014
    • Recruiting
    • CHGUV
    • Contact: Carolina S Romero Garcia, PhD
  • Valencia, Spain
    • Recruiting
    • CHGUV
    • Contact: Carolina Romero García, PhD; Phone Number: +34654541555; Email: romero_carolinasol@gva.es
    • Contact: Adina Iftimi, PhD; Phone Number: +34635992819

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients with anaesthesia and eeg monitoring

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oscillations related to pain in the EEG	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.	since start of surgery until the end

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Chronic pain	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 .	after surgery until 1 year post surgery
opiod consumption	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.	during surgery until 1 year post surgery

Collaborators and Investigators

• Sponsor: Hospital General Universitario de Valencia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 31/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research board decision was not to share Individual Participant Data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No