RecruitingACTRN12618001662257

Can the use of a non-invasive monitor (QNox) predict stronger pain after an operation?

The accuracy of the EEG-based qNox monitor to predict moderate-severe acute postoperative pain in peri-operative patients

Sponsor

Prof THomas Ledowski

Enrollment

150 participants

Start Date

Oct 30, 2018

Study Type

Observational

Conditions

moderate-severe pain after surgery

Summary

The qNox monitoring System (Conox Monitor; Fresenius Kabi) is an electroencephalogram-based (sticky electrode on forehead) dimensionless score (0-100) which claims to reflect levels of analgesia in anaesthetized patients. Higher levels of the score may reflect higher levels of noxious stimulation, or a higher likelihood of a patient to respond to noxious stimuli. Aim of the current study is to investigate whether a higher qNox score during, and at the end of surgery may be associated with a higher likelihood of significant postoperative pain. 150 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia and state entropy depth of anaesthesia monitoring will be included. In addition to standard monitoring, a row of sticky electrodes (similar to the ones used for monitoring the long-established state entropy monitor) will be placed on the patients’ forehead. No other intervention is done for the trial. QNox will be monitored specifically at the end of surgery before patient arousal. Once awake in recovery, patients’ pain will be rated on a numeric rating scale (0-10) every 5 minutes (as per recovery room routine). The first 4 pain ratings will be used to analyse any relationship between qNox and postoperative pain. No other study-related intervention will take place. Participating patients will neither be inconvenienced nor harmed in any way by inclusion in this trial.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Post-operative pain is common after surgery and can be difficult to predict and manage effectively. If doctors could identify which patients are likely to experience significant pain before they even wake up from anaesthesia, they could prepare better pain management strategies in advance. The qNox monitor uses brain wave signals (EEG) recorded from a forehead electrode during anaesthesia to generate a score that may reflect how much pain stimulation the patient is experiencing. This study tests whether a higher qNox score recorded at the end of surgery — just before a patient wakes up — predicts a higher chance of experiencing significant pain in the recovery room. One hundred and fifty patients scheduled for non-emergency surgery will have the qNox monitoring applied in addition to their standard anaesthesia monitoring. No other change to their care is made — the device just records, and researchers compare the scores to pain ratings once patients are awake. To be eligible you need to be 18 or older and scheduled for non-emergency surgery under sevoflurane-based general anaesthesia. People with epilepsy, severe mental disorders, chronic pain on opioid medications, or who cannot communicate pain on a standard scale are not eligible. Participation involves only the placement of forehead electrodes — there are no extra procedures or medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Monitoring of the electroencephalogram-based QNox score during anaesthesia and recording 4 pain scores (5 minutely for first 15 min) after admission of a patient to the recovery room after surgery, as well as the total consumption of opioid-analgesics during the entire stay of a patient in the recovery room. This involves placement of a sticky sensor (single use QNox sensor) on the patient's forehead, as well as the patients to rate their pain (0-10) three times on a numeric rating scale for 15 min after recovery room admision.

Locations(1)

Royal Perth Hospital - Perth

WA, Australia

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ACTRN12618001662257