The Effects of Body Mass Index on Erector Spinae Plane Block Analgesia
NCT06257953
Acute Pain, Body Mass Index
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06313320
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.
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Notify Me18 year–60 year
All sexes
Observational
Hospital Clinico de la Universidad de Chile, Santiago, RM, Chile
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From PACU Admission to PACU Discharged, an average of 2 hours
Pain is evaluated several times during PACU stay using the Numeric Rating Scale (from 0 to 10). Discrete Numerical Variable
Time frame: From PACU Admission to PACU Discharged, an average of 72 hours
Total opioid administered during PACU stay in Morphine Milligram Equivalent (MME). Continuous Numerical Variable.
Time frame: From PACU discharged to 24 hours after PACU discharged
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.
Time frame: 7 days after the surgery (+- 1 day)
Pain of any intensity (Numeric Rating Scale >1) reported by the patient 7 days after the surgery
Time frame: 30 days after surgery (+- 3 day)
Pain of any intensity (Numeric Rating Scale >1) reported by the patient 30 days after the surgery
University of Chile
Other
Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain
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