Exploring brain signals related to postoperative pain
Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain
This study is trying to see if brain signals during surgery can help predict how much pain people will feel after having laparoscopic abdominal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Chile Academic / other |
| Locations | 2 sites (Santiago, RM and 1 other locations) |
| Trial ID | NCT06313320 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between intraoperative electroencephalographic (EEG) signals and the severity of acute postoperative pain in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. The study will utilize a standardized Intraepidermal Electrical Stimulation (IES) protocol to collect EEG data at various stages of the surgical procedure. Participants will receive calibrated electrical stimuli to assess their pain thresholds, and their pain levels will be monitored using a Numeric Pain Rating Scale in the post-anesthesia care unit.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective laparoscopic abdominal surgery under general anesthesia with an American Society of Anesthesiologist Performance Status of I or II.
Not a fit: Patients with a body mass index over 35, severe neuropsychiatric illnesses, or those with a history of chronic pain conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for postoperative patients by identifying EEG biomarkers associated with pain severity.
How similar studies have performed: While the approach of using EEG to assess pain is innovative, similar studies have shown promise in correlating brain activity with pain perception, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologist Performance Status I or II * Scheduled for elective laparoscopic abdominal surgery under General Anesthesia Exclusion Criteria: * Body Mass Index \> 35 kg/m2 * Past history or suspected difficult airway * Craniofacial malformations * Use of regional anesthesia technique during or after the surgery * Severe arrhythmia or use of a pacemaker device * Severe neuropsychiatric illness (Mayor depression, bipolar disorder, schizophrenia) * Regular use of psychoactive drugs * Any injury in the right hand * Past history of peripheral neuropathy * Diabetes Mellitus * Known lesion in the spinothalamic tract. * Analgesics used in the past 72 hours * Known allergy to propofol * Previous diagnosis of a condition associated with chronic pain (such as fibromyalgia, rheumatoid arthritis, osteoarthritis, migraine)
Where this trial is running
Santiago, RM and 1 other locations
- Hospital Clinico de la Universidad de Chile — Santiago, Rm, Chile (Not_yet_recruiting)
- Centro de Investigacion Clinica Avanzada — Santiago, Chile (Recruiting)
Study contacts
- Principal investigator: Rodrigo Gutierrez, MD, PhD — University of Chile
- Study coordinator: Rodrigo Gutierrez, MD, PhD
- Email: rodrgutierrez@uchile.cl
- Phone: +56995993665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.