Trial Review

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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] 287141 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute postoperative pain 295689 0
Condition category
Condition code
Anaesthesiology 295966 295966 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
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] 292403 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295646 0
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] 295646 0
first 15 minutes in the recovery room
Secondary outcome [1] 316086 0
relationship between surgical pleth index and state entropy readings during emergence from anaesthesia
Timepoint [1] 316086 0
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?
No
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
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4077 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 4078 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 10021 0
6000 - Perth
Recruitment postcode(s) [2] 10039 0
6112 - Mount Nasura

Funding & Sponsors
Funding source category [1] 291698 0
Self funded/Unfunded
Name [1] 291698 0
Country [1] 291698 0
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] 290374 0
Individual
Name [1] 290374 0
Dr. Jan Hruby
Address [1] 290374 0
Armadale Health Service, 3056 Albany Hwy
Mt. Nasura, WA, 6112
Country [1] 290374 0
Australia
Other collaborator category [1] 278534 0
Individual
Name [1] 278534 0
Dr. Jan Hruby
Address [1] 278534 0
Armadale Health Service, 3056 Albany Hwy
Mt. Nasura, Western Australia, 6112
Country [1] 278534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293222 0
Ethics Committee of the South Metropolitan Health Service
Ethics committee address [1] 293222 0
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] 293222 0
Australia
Date submitted for ethics approval [1] 293222 0
Approval date [1] 293222 0
04/06/2015
Ethics approval number [1] 293222 0
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 58982 0
Prof Thomas Ledowski
Address 58982 0
Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000
Country 58982 0
Australia
Phone 58982 0
+61892241036
Fax 58982 0
Email 58982 0
[email protected]
Contact person for public queries
Name 58983 0
Prof Thomas Ledowski
Address 58983 0
Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000
Country 58983 0
Australia
Phone 58983 0
+61892241036
Fax 58983 0
Email 58983 0
[email protected]
Contact person for scientific queries
Name 58984 0
Prof Thomas Ledowski
Address 58984 0
Royal Perth Hospital Dept. of Anaesthesia and Pain Medicine, Level 4 North Block, RPH
Wellington Street, Perth, WA, 6000
Country 58984 0
Australia
Phone 58984 0
+61892241036
Fax 58984 0
Email 58984 0
[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
SourceTitleYear of PublicationDOI
EmbaseSurgical pleth index: Prediction of postoperative pain and influence of arousal.2016https://dx.doi.org/10.1093/bja/aew226
N.B. These documents automatically identified may not have been verified by the study sponsor.