ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001662257

Ethics application status

Approved

Date submitted

14/09/2018

Date registered

9/10/2018

Date last updated

6/02/2019

Date data sharing statement initially provided

6/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

moderate-severe pain after surgery

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Predictive value of the QNox score for the prediction of moderate-severe postoperative pain.
Assessed by the placement of a sensor electrode on the paricipants forehead during surgery and recording of the QNox score at the end of the procedure. Participants then rate their pain (0-10) on a verbal rating scale four times for 15 min after recovery room admission.

Timepoint [1]

Qnox monitored at the end of surgery, prior to patient arousal. Primary endpoint is the prefictive value of the QNox score for the highest Of four Pain scores measured four
times (T0, T5, T10, T15) for 15 minutes after admission of the patient to the recovery room (once able to communicate their pain effectively).

Secondary outcome [1]

nil

Timepoint [1]

nil

Eligibility

Key inclusion criteria

Patients at/over 18 years of age scheduled for non-emergency surgery and anaesthesia with sevoflurane/opioid

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded from further analysis if they lack sufficient English language skills to communicate pain on a self-rated pain scale, have a condition or medication known or suspected of interacting with the acquisition of the eeg data (i.e. know epilepsy, known severe mental disorder), chronic pain (with opioid medication at home), use of ketamine at home or perioperatively within 30 min prior to the commencement of QNOX measurements, abuse of amphetamines or opioids, allergy to sticky tape.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Statistical analysis:

Data exploration for normal distribution: K-S Test; investigation of the predictive value of the score: receiver-operating curves for qNox and exploration of the "best-fit" cut-off point with the combined highest sensitivity and specificity (Youden's Index); comparison between pain groups: students T-test, ANOVA or appropriate non-parametric alternatives (if tested non normally distributed).
Sample size estimate: In order to detect any significant predictive value of qNox for postoperative pain prediction (as defined as an area under the receiver-operating curve of at least 0.7) 50 subjects in each pain category (no-mild vs. moderate-severe) are required. As, in our experience, the ratio between these pain groups may be as low as 1:2, we estimate that 150 subjects are required to prevent loss of statistical power.

The level of significance to be used is P = 0.05
In addition to the above described methods data of 100 patients will be used to calculate the qnox with the highest combined sensitivity/specificity to distinguish between no-mild vs moderate-severe pain in the recovery room. The calculated cut-off value will the be tested prospectively in the next 50 patients for the purpose of validation. This analysis will only take place at the end of the full data collection (n=150) and will not exclude analysis/calculation of a "best-fit" qnox cut-off value for the entire data set.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/10/2018

Actual

30/10/2018

Date of last participant enrolment

Anticipated

15/04/2019

Actual

Date of last data collection

Anticipated

15/04/2019

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

197 Wellington St, Perth WA 6000

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof THomas Ledowski

Address

Royal Perth Hospital
Dept. of Anaesthesia
197 Wellington St, Perth WA 6000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee (EC00265)

Ethics committee address [1]

Level 2, Education Building, Fiona Stanley Hospital

14 Barry Marshall Parade, MURDOCH WA 6150

Postal address: Locked Bag 100, PALMYRA DC WA 6961

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/09/2018

Approval date [1]

29/10/2018

Ethics approval number [1]

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Thomas Ledowski

Address

Royal Perth Hospital
Dept. of Anaesthesia
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 (08) 92241036

Fax

thomas.ledowski@health.wa.gov.au

Contact person for public queries

Name

Thomas Ledowski

Address

Royal Perth Hospital
Dept. of Anaesthesia
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 (08) 92241036

Fax

thomas.ledowski@health.wa.gov.au

Contact person for scientific queries

Name

Thomas Ledowski

Address

Royal Perth Hospital
Dept. of Anaesthesia
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 (08) 92241036

Fax

thomas.ledowski@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The investigators reserve the right to withhold the data set from certain requesting parties in case the request is not related to the intend to verify our data analysis (i.e. by a related ethics committee or research governance institution) but likely to be used for commercial interest or in any way that is not endorsed by the investigators.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Predicting acute postoperative pain by the Qnox score at the end of surgery: a prospective observational study.	2020	https://dx.doi.org/10.1016/j.bja.2019.09.041

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically