Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001596190
Ethics application status
Approved
Date submitted
28/10/2019
Date registered
20/11/2019
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does intraoperative monitoring of the nociception level index (NOL) allow a prediction of the severity of acute postoperative pain?
Scientific title
Does intraoperative monitoring of the nociception level index (NOL) allow a prediction of the severity of acute postoperative pain?
Secondary ID [1] 299660 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute pain 314994 0
Condition category
Condition code
Anaesthesiology 313331 313331 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Continuous monitoring of the nociception level index (NOL) throughout surgery and monitoring of postoperative pain score for 15 minutes after admission to the recovery room.
NOL is measured via a single-use non-invasive (sticky) electrode on one finger.
Intervention code [1] 315920 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321809 0
acute postoperative pain (0-10 numerical rating scale)
Timepoint [1] 321809 0
Assessment at 0, 5,10 and 15 minutes after arousal in the recovery room
Secondary outcome [1] 376271 0
none
Timepoint [1] 376271 0
none

Eligibility
Key inclusion criteria
Adult patients (both sexes) scheduled for non-emergency surgery under general anaesthesia with opioid/sevoflurane at the Royal Perth Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from further analysis if they lack sufficient English language skills to consent and/or to communicate pain on a self-rated pain scale, have a condition or medication known or suspected of interacting with the acquisition of the data (i.e. know severe peripheral neuropathy, known severe mental disorder), chronic pain (with opioid medication at home), use of ketamine at home, 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 NOL 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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15062 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 28352 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 304133 0
Hospital
Name [1] 304133 0
Royal Perth Hospital
Country [1] 304133 0
Australia
Funding source category [2] 304134 0
Hospital
Name [2] 304134 0
Dept of Anaesthesia
Country [2] 304134 0
Australia
Primary sponsor type
Individual
Name
Thomas Ledowski
Address
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 304364 0
None
Name [1] 304364 0
Address [1] 304364 0
Country [1] 304364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304617 0
Human Ethics Committee South Metropolitan Health Service
Ethics committee address [1] 304617 0
Ethics committee country [1] 304617 0
Australia
Date submitted for ethics approval [1] 304617 0
21/10/2019
Approval date [1] 304617 0
25/10/2019
Ethics approval number [1] 304617 0
RGS3573

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97602 0
Prof Thomas Ledowski
Address 97602 0
Dept of Anaesthesia Royal Perth Hospital 197 Wellington Street Perth WA 6000
Country 97602 0
Australia
Phone 97602 0
+61 08 92242244
Fax 97602 0
Email 97602 0
[email protected]
Contact person for public queries
Name 97603 0
Thomas Ledowski
Address 97603 0
Dept of Anaesthesia Royal Perth Hospital 197 Wellington Street Perth WA 6000
Country 97603 0
Australia
Phone 97603 0
+61 08 92242244
Fax 97603 0
Email 97603 0
[email protected]
Contact person for scientific queries
Name 97604 0
Thomas Ledowski
Address 97604 0
Dept of Anaesthesia Royal Perth Hospital 197 Wellington Street Perth WA 6000
Country 97604 0
Australia
Phone 97604 0
+61 08 92242244
Fax 97604 0
Email 97604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• data will be shared with journal editors or researchers on reasonable request - however, the investigators reserve the right to questions the reasons for data sharing requests

Conditions for requesting access:
• -

What individual participant data might be shared?
• de-identified raw data (underlying published results only) in SPSS data file format

What types of analyses could be done with individual participant data?
• The de-identified raw data will be made available for meta-analyses or research work which requires access to such data (once approved by an ethics committee as well as the investigators of the current trial)

When can requests for individual participant data be made (start and end dates)?
From:
data will available from publication of the results until 2 years from this time point.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Requests can be made to the chief investigator via email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
SourceTitleYear of PublicationDOI
EmbaseNociception level index: do intra-operative values allow the prediction of acute postoperative pain?.2022https://dx.doi.org/10.1007/s10877-021-00654-8
N.B. These documents automatically identified may not have been verified by the study sponsor.