Intraoperative Electroencephalographic Biomarkers of Postoperative Pain

Nociceptive Pain Clinical Trial

Official title:

Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313320
• Other study ID #: OAIC1344-23
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: University of Chile
• Contact: Rodrigo Gutierrez, MD, PhD
• Phone: +56995993665
• Email: rodrgutierrez[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This is a prospective minimal-risk observational study to collect and analyze EEG data during intraepidermal electrical stimulation in patients receiving general anesthesia (GA) for abdominal surgery. To collect nociception-related EEG signal during GA the investigators designed a standardized Intraepidermal Electrical Stimulation (IES) Protocol. The intensity of the electrical stimulus will be calibrated to each participant perception pre-surgery, with 3 different intensities: sensitivity threshold, mild-pain threshold, and moderate-pain threshold. The IES will be administered several times throughout the surgical procedure: a) At baseline, prior to induction of GA, b) Three minutes after loss of consciousness, c) Five minutes after fentanyl administration and orotracheal intubation, d) Five minutes after first incision and every 20 minutes until the end of the surgery, and f) After surgery ends and before extubation. To standardize the anesthesia management as much as possible, all patients will be attended by a reduced number of anesthesiologists. The hypnosis will be achieved with propofol, while analgesia will be mainly achieved with either fentanyl or remifentanil. EEG will be recorded with a 32-channel high standard equipment. Once the patient arrives to the Post-Anesthesia Care Unit (PACU), the investigators will record the pain reported by the patient using the Numeric Pain Rating Scale every 15 minutes during the first hour, and every 30 minutes until patient is discharged from the PACU. Also, the investigators will both, record opioid administration through the surgery and estimate their effect-site concentration with pharmacokinetic/pharmacodynamic models. Besides, the investigators will measure opioid plasmatic concentrations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nociceptive Pain
• Pain Postoperative
• Pain, Postoperative

Locations

Country	Name	City	State
Chile	Centro de Investigacion Clinica Avanzada	Santiago
Chile	Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Consumption in PACU	Total opioid administered during PACU stay in Morphine Milligram Equivalent (MME). Continuous Numerical Variable.	From PACU Admission to PACU Discharged, an average of 72 hours
Secondary	Maximum Pain at 24h	Pain is evaluated several times during hospital stay using the Numeric Rating Scale (from 0 to 10). This outcome corresponds to the maximum pain reported by the patient during the time frame. Discrete Numerical Variable.	From PACU discharged to 24 hours after PACU discharged
Secondary	Presence of surgical related pain at day 7	Pain of any intensity (Numeric Rating Scale >1) reported by the patient 7 days after the surgery	7 days after the surgery (+- 1 day)
Secondary	Presence of surgical related pain at day 30	Pain of any intensity (Numeric Rating Scale >1) reported by the patient 30 days after the surgery	30 days after surgery (+- 3 day)