ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001475336

Ethics application status

Approved

Date submitted

16/10/2017

Date registered

19/10/2017

Date last updated

19/10/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

SurgicalPleth Index for the prediction of acute postoperative pain

Scientific title

SurgicalPleth Index for the prediction of acute postoperative pain

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

postoperative pain

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

Surgical Pleth Index will be recorded intraoperatively in 200 patients anaesthetized with sevoflurane/opioid during the last 5 minutes of an operation, just before the anaesthetic is lightened. Thereafter, postoperative pain will be recorded 3 times (for 15 minutes post recovery room admission) in the revcovery room (on a 0-10 numeric rating scale).

Intervention code [1]

Not applicable

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Prospectively test the hypothesis that a SPI > 30 at the end of surgery may predict moderate-severe (pain >3 on 0-10 numeric rating scale) postoperative pain.

Timepoint [1]

Within the first 15 minutes after recovery room admission.

Secondary outcome [1]

To investigate the correlation between age and the predictive probability of SPI (for the prediction of postoperative pain in the recovery room)

Timepoint [1]

pain measure within 15 minutes after recovery room admission

Eligibility

Key inclusion criteria

Patients aged 18-100 yrs. scheduled for anaesthesia (non emergency) with sevoflurane/opioid.

Minimum age

18 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Regular or intraoperative medication (prior to SPI assessment) known or suspected to interact with the assessment of SPI (i.e. ketamine, clonidine, neostigmine, beta-receptor blockers, incl. metaraminol/ephedrine within 10 minutes of the SPI assessment), pacemaker, severe autonomous dysfunction, significant cardiac arrhythmia (i.e. AF), Aboriginal patients, patients with an impaired ability to rate their level of postoperative pain on a NRS (i.e. significant mental impairment, dementia), surgical tourniquet at the time of and/or < 10 minutes prior to SPI assessment, any analgesic medication between SPI assessment and first pain score in the recovery room (note: extremely rare)

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

All data will be tested for normal distribution (KS test). Data may be described as mean (standard deviation)/median percentiles, as appropriate. For the assessment of SPI prediction of pain the analysis of the receiver operating characteristics (ROC) will be used. In addition, the predictive probability of the SPI cut-off (30) will be calculated via the excel macro PK MACRO (by Warren D. Smith). The differences between PK values for different age groups/anaesthetic techniques will be calculated via the macro PKD. The influence of age will be calculated via a linear regression model.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/11/2017

Actual

Date of last participant enrolment

Anticipated

1/10/2018

Actual

Date of last data collection

Anticipated

1/10/2018

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Armadale Kelmscott Memorial Hospital - Armadale

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6112 - Armadale

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

East Metropolitan Health Service

Address [1]

02-118 Murdoch Dr, Murdoch WA 6150

Country [1]

Australia

Primary sponsor type

Individual

Name

Thomas Ledowski

Address

Anaesthesiology Unit
University of Western Australia
35 Stirling Hwy
Crawley, WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the South Metro Health Service

Ethics committee address [1]

1 Robin Warren Drive
Murdoch, WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/09/2017

Ethics approval number [1]

000523

Summary

Brief summary

Background: The surgical pleth index (SPI, GE Healthcare, Helsinki, Finland) is a 0-100 score derived from the intraoperative non-invasive monitoring of oxygen saturation. Simply speaking, SPI is a software using existing data. The SPI score claims to reflect states of intraoperative pain. A previous investigation by us published in the British Journal of Anaesthesia (Br J Anaesth. 2016 Sep;117(3):371-4) found that a SPI > 30 at the end of surgery (prior to awakening) predicted moderate-severe postoperative pain. 
Objectives: As such prediction would provide a significant benefit for the pre-emptive treatment of pain, the proposed project aims to prospectively validate the SPI cut-off published by us in a larger cohort. In addition, we would like to evaluate the influence of age on the SPI cut-off value predicting moderate-severe pain, as well as the influence of a different anaesthetic technique (total intravenous anaesthesia) on the predictive value of SPI. The latter sub-group will be investigated by our collaborators in Kiel, Germany.
Within WA Health 200 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia will be included in the study. Patients will receive a completely standard anaesthetic.
At the end of surgery, SPI will be recorded minutely for 5 minutes. As outlined above, this simply requires recording of displayed SPI values. As SPI uses available data derived from standard monitoring, no discomfort or risk is associated with study inclusion. After awakening, 3 pain scores (numeric rating scales 0-10) will be recorded in the recovery room. The 5-minutely recording of pain scores is standard protocol in the involved hospitals and does hence not at all inconvenience patients. Apart from SPI and pain readings, only very limited data are recorded.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Thomas Ledowski

Address

Medical School
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 9224 0210

Fax

[email protected]

Contact person for public queries

Name

Thomas Ledowski

Address

Medical School
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 9224 0210

Fax

[email protected]

Contact person for scientific queries

Name

Thomas Ledowski

Address

Medical School
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 9224 0210

Fax

[email protected]

No information has been provided regarding IPD availability

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	Surgical pleth index: prospective validation of the score to predict moderate-to-severe postoperative pain.	2019	https://dx.doi.org/10.1016/j.bja.2018.10.066

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

Trial Review

Documents added manually

Documents added automatically