Intraoperative Electroencephalographic Biomarkers of Postoperative Pain

NCT06313320 | Completed

• 1 other identifier: OAIC1344-23
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to explore whether specific intraoperative EEG signals (brain waves or neuronal electrical activity) are associated with the severity of acute postoperative pain.

Conditions

Pain Postoperative; Nociceptive Pain

Keywords

Pain; Nociception; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• Maximum Pain in PACU

  Pain is evaluated several times during PACU stay using the Numeric Rating Scale (from 0 to 10). Discrete Numerical Variable

  From PACU Admission to PACU Discharged, an average of 2 hours

Secondary Outcomes (4)

• Opioid Consumption in PACU

  From PACU Admission to PACU Discharged, an average of 72 hours

• Maximum Pain at 24h

  From PACU discharged to 24 hours after PACU discharged

• Presence of surgical related pain at day 7

  7 days after the surgery (+- 1 day)

• Presence of surgical related pain at day 30

  30 days after surgery (+- 3 day)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult patients schedule for elective abdominal surgery under general anesthesia.

You may qualify if:

• American Society of Anesthesiologist Performance Status I or II
• Scheduled for elective laparoscopic abdominal surgery under General Anesthesia

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7563215, Chile

Location

Centro de Investigacion Clinica Avanzada

Santiago, Chile

Location

Related Publications (4)

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

  PMID: 24237004 BACKGROUND

• Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.

  PMID: 30983589 BACKGROUND

• Garcia PS, Kreuzer M, Hight D, Sleigh JW. Effects of noxious stimulation on the electroencephalogram during general anaesthesia: a narrative review and approach to analgesic titration. Br J Anaesth. 2021 Feb;126(2):445-457. doi: 10.1016/j.bja.2020.10.036.

  PMID: 33461725 BACKGROUND

• Baharloo R, Principe JC, Fillingim RB, Wallace MR, Zou B, Crispen PL, Parvataneni HK, Prieto HA, Machuca TN, Mi X, Hughes SJ, Murad GJA, Rashidi P, Tighe PJ. Slow Dynamics of Acute Postoperative Pain Intensity Time Series Determined via Wavelet Analysis Are Associated With the Risk of Severe Postoperative Day 30 Pain. Anesth Analg. 2021 May 1;132(5):1465-1474. doi: 10.1213/ANE.0000000000005385.

  PMID: 33591118 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will collect plasma at 3 timepoints during surgery.

MeSH Terms

Conditions

Pain, Postoperative; Nociceptive Pain; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rodrigo Gutierrez, MD, PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: May 1, 2024
• Primary Completion: February 15, 2026
• Study Completion: March 23, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CL (2)