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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximum Pain at 24h |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients schedule for elective abdominal surgery under general anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Gutierrez, MD, PhD | University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico de la Universidad de Chile | Santiago | RM | 7563215 | Chile | ||
| Centro de Investigacion Clinica Avanzada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24237004 | Background | 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. | |
| 30983589 | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059226 | Nociceptive Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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The investigators will collect plasma at 3 timepoints during surgery.
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 |
| 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) |
| 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) |
| Santiago |
| Chile |
| 33461725 | 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. |
| 33591118 | 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. |
| D012816 | Signs and Symptoms |