EEGpain: Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia

Sponsor
Hospital General Universitario de Valencia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05873894
Collaborator
(none)
50
2
67.1
25
0.4

Study Details

Study Description

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 GA 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.

Condition or Disease Intervention/Treatment Phase
  • Device: EEG

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia: Characterisation of EEG Patterns Secondary to Pain
Actual Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2027
Anticipated Study Completion Date :
Dec 15, 2028

Outcome Measures

Primary Outcome Measures

  1. Oscillations related to pain in the EEG [since start of surgery until the end]

Secondary Outcome Measures

  1. Incidence of Chronic pain [after surgery until 1 year post surgery]

  2. Opiod consuption [during surgery until 1 year post surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHGUV Valencia Spain 46014
2 CHGUV Valencia Spain

Sponsors and Collaborators

  • Hospital General Universitario de Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carolina Soledad Romero Garcia, MD, PhD, Professor, Hospital General Universitario de Valencia
ClinicalTrials.gov Identifier:
NCT05873894
Other Study ID Numbers:
  • 31/2020
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023