ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000804583

Ethics application status

Approved

Date submitted

22/07/2015

Date registered

3/08/2015

Date last updated

3/08/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Correlation between Surgical Pleth Index and acute postoperative pain in the recovery room

Scientific title

Surgical patients: observation of intra-operative surgical pleth index and its correlation with acute postoperative pain

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

acute 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

observation of surgical pleth index over the last 15 minutes of anaesthesia and observation of pain scores (on 0-10 numeric rating scale) during the first 15 minutes in the recovery room.

Intervention code [1]

Not applicable

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Correlation between surgical pleth index scores during the last 15 min of surgery with the pain scores obtained from patients during the first 15 min of their postoperative recovery. Pain scores will be assessed using a 0 (no pain) - 10 (worst pain) numeric rating scale.

Timepoint [1]

first 15 minutes in the recovery room

Secondary outcome [1]

relationship between surgical pleth index and state entropy readings during emergence from anaesthesia

Timepoint [1]

during emergence from anaesthesia

Eligibility

Key inclusion criteria

Patients scheduled for elective or urgent surgery under general anaesthesia (including laryngeal mask airway [if planned to be removed in the operating theatre] or endotracheal tube, state entropy monitoring) with sevoflurane. Age: 18 -95 yrs.

Minimum age

18 Years

Maximum age

95 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Incapacity to consent, age < 18 yrs, poorly treated diabetes, severe peripheral or cardiac neuropathy, pacemaker, treatment (infusion) with vasoactive medication, ketamine during the data acquisition interval, any intraoperative treatment with ketamine, beta-receptor blockers, clonidine, beta-receptor agonists (i.e. Ventolin) or any other drug suspected to interact with the sympatho-vagal balance. Surgery requiring a tourniquet (unless already deflated at start of intra-operative data acquisition interval).

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Level of significance: Alpha = 5%, Beta = 20%

Correlation to be detected: 0.3

67 patients are required for above parameters. We aim to include n=70 to account for missing data (i.e. withdrawal, technical difficulties).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

14/08/2015

Actual

Date of last participant enrolment

Anticipated

31/12/2015

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

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 - Mount Nasura

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Thomas Ledowski

Address

Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth WA 6000

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr. Jan Hruby

Address [1]

Armadale Health Service, 3056 Albany Hwy
Mt. Nasura, WA, 6112

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr. Jan Hruby

Address [1]

Armadale Health Service, 3056 Albany Hwy
Mt. Nasura, Western Australia, 6112

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the South Metropolitan Health Service

Ethics committee address [1]

SIRO Research Ethics & Governance Unit

Southern Metropolitan Health Service

Level 2, Southern Research Facility (Perkins Building)

Fiona Stanley Hospital 102-118 Murdoch Drive 

MURDOCH WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/06/2015

Ethics approval number [1]

15/23

Summary

Brief summary

 Surgical Pleth Index (SPI, GE Healthcare) has been suggested to be a potentially useful parameter to
assess the depth of analgesia (freedom of pain) in patients under general anaesthesia. SPI is completely risk free and requires no extra monitoring as is simply uses existing data from standard anaesthesia monitoring (from peripheral oxygen saturation sensor) to calculate a 0-100 analgesia score. Though experiments have shown that SPI scores may “respond” (i.e. going up with a painful stimulus), it is unclear whether the score may be useful to predict acute postoperative pain the recovery room. Aim of this purely observational study is to monitor SPI in 70 patients scheduled for elective surgery and to observe and record SPI data during the last approx.15 minutes of surgery until the patient wakes up from anaesthesia. This data will be compared with the first 15 minutes of 3-minutely assessed postoperative pain (0-10 numeric rating scale) in the recovery room (time counting from when patients are capable of pain self-rating). All assessments of interest for this study are standard practice of intraoperative monitoring and no additional monitoring is required for this study. The sole difference to standard practice is that the data from the anaesthesia monitor will be downloaded onto a laptop PC for analysis of the correlation between SPI and postoperative acute pain scores

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Thomas Ledowski

Address

Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000

Country

Australia

Phone

+61892241036

Fax

thomas.ledowski@health.wa.gov.au

Contact person for public queries

Name

Thomas Ledowski

Address

Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000

Country

Australia

Phone

+61892241036

Fax

thomas.ledowski@health.wa.gov.au

Contact person for scientific queries

Name

Thomas Ledowski

Address

Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000

Country

Australia

Phone

+61892241036

Fax

thomas.ledowski@health.wa.gov.au

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: Prediction of postoperative pain and influence of arousal.	2016	https://dx.doi.org/10.1093/bja/aew226

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

Trial Review

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Documents added manually

Documents added automatically