PainEEGpainNCT05873894
Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia
An observational study of Pain, run by Hospital General Universitario de Valencia at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- EEG
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 15 May 2023to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with anaesthesia and eeg monitoring
Who may be able to join
- Adult patients that undergo schedule neurosurgery with neurophysiological monitorisation.
- American Society of Anaesthesiologist physical status (ASA) I-IV.
Who cannot join
- Pregnancy
- Obstructive hydrocephaly with or with a derivative catheter.
- Patients with neurostimulator
- Emergency surgery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paula Solis, MD contact
Spain2 sites, 2 recruiting
- Recruiting
CHGUV
Valencia, 46014
Carolina S Romero Garcia, PhD
- Recruiting
CHGUV
Valencia
Carolina Romero García, PhD, +34654541555, romero_carolinasol@gva.es
Adina Iftimi, PhD, +34635992819
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- EEG
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
EEG recordings and analysis. Sensory evoked potentials analysis Motor evoked potentials studies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: since start of surgery until the end
Secondary outcomes (2)
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 .
Measured: 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.
Measured: during surgery until 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 May 2023
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Soledad Romero Garcia, MD, PhD, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873894
- Sponsor's protocol ID
- 31/2020
- Acronym
- EEGpain
- Status last verified
- Jul 2023
- First submitted
- 15 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research board decision was not to share Individual Participant Data
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia: Characterisation of EEG Patterns Secondary to Pain
- ClinicalTrials.gov ID
- NCT05873894
- Acronym / sponsor ID
- EEGpain / 31/2020
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital General Universitario de ValenciaUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with anaesthesia and eeg monitoring
Key inclusion criteria (2 listed)
- Adult patients that undergo schedule neurosurgery with neurophysiological monitorisation.
- American Society of Anaesthesiologist physical status (ASA) I-IV.
Key exclusion criteria (4 listed)
- Pregnancy
- Obstructive hydrocephaly with or with a derivative catheter.
- Patients with neurostimulator
- Emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGEEG recordings and analysis. Sensory evoked potentials analysis Motor evoked potentials studies | Device | – |
Primary outcome
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.
2 secondary outcomes
Incidence of Chronic pain
Time frame: after surgery until 1 year post surgery
opiod consumption
Time frame: during surgery until 1 year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No. Research board decision was not to share Individual Participant Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paula Solis, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Hospital General Universitario de Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina S Romero, PhD (+34963187554, romero_carolinasol@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillations related to pain in the EEG (time frame: since start of surgery until the end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.