Clinical trial NCT05873894: Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia
Official title: Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia: Characterisation of EEG Patterns Secondary to Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with anaesthesia and eeg monitoring

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oscillations related to pain in the EEG
timeFrame: since start of surgery until the end
Secondary outcomes:
measure: Incidence of Chronic pain
timeFrame: after surgery until 1 year post surgery
measure: opiod consumption
timeFrame: during surgery until 1 year post surgery
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: CHGUV
city: Valencia
country: Spain
facility: CHGUV
Study officials:
References: