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Trial registered on ANZCTR


Registration number
ACTRN12612001193864
Ethics application status
Approved
Date submitted
9/11/2012
Date registered
13/11/2012
Date last updated
13/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Analgesia Nociception Index: evaluation as a new parameter for acute postoperative pain
Scientific title
Investigation of the Analgesia Nociception Index as a measure of acute postoperative pain in adult patients after sevoflurane-based general anaesthesia
Secondary ID [1] 281516 0
nil
Universal Trial Number (UTN)
U1111-1136-9207
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute postoperative pain 287785 0
Condition category
Condition code
Anaesthesiology 288137 288137 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of the relationship between Analgesia Nociception Index (ANI) and acute pain as rated on a 0-10 numeric rating scale during the stay in the postoperative recovery unit. The rating will be repeated every 5 minutes until recovery room discharge (= completion of the observation period).
ANI is a 0-100 index which is based on the analysis of heart rate variability. By this means, ANI claims to be able to assess the strength of parasympathetic activity. As the latter is likely to decrease with acute pain, a low ANI may indicate pain whereas a high ANI may reflect a more comfortable state.
The electrocardiogram (ECG) signal for ANI is derived from 2 sticky single use electrodes which are place in V1 and V5 ECG position on the chest.
Intervention code [1] 286035 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288335 0
Differences in Analgesia Nociception Index at different states of acute pain
Timepoint [1] 288335 0
5 minutely during stay of patients in the postoperative recovery unit
Secondary outcome [1] 299904 0
correlation between Analgesia Nociception Index and acute pain measured on a 0-10 numeric rating scale
Timepoint [1] 299904 0
5 minutely during stay of patients in the postoperative recovery unit

Eligibility
Key inclusion criteria
Adult patients (ASA 1-3) scheduled for non-emergency surgery
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medication with betablockers, vasoactive drugs, ketamine clonidine, glycopyrrolate, atropine or neostigmine; pacemaker

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286297 0
Self funded/Unfunded
Name [1] 286297 0
Prof. Thomas Ledowski
Address [1] 286297 0
Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington Street Campus, Perth WA 6000, Australia
Country [1] 286297 0
Australia
Primary sponsor type
Individual
Name
Prof. Thomas Ledowski
Address
Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington Street Campus, Perth WA 6000, Australia
Country
Australia
Secondary sponsor category [1] 285090 0
None
Name [1] 285090 0
Address [1] 285090 0
Country [1] 285090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288372 0
Ethics Committee of the Royal Perth Hospital
Ethics committee address [1] 288372 0
Level 5 Clonial House
Royal Perth Hospital
Perth WA 6000
Ethics committee country [1] 288372 0
Australia
Date submitted for ethics approval [1] 288372 0
Approval date [1] 288372 0
23/04/2012
Ethics approval number [1] 288372 0
EC 2012 50

Summary
Brief summary
Monitoring pain in patients who are semi-conscious after an operation under general anaesthesia can be difficult. The Analgesia Nociception Index (ANI) is a monitor that claims to enable anaesthetists to monitor pain even when patients cannot communicate their pain directly. ANI is based on an analysis of the ECG signal which finally allows an estimate of the stress reaction a patient experiences during an episode of pain. The ANI score is a 0-100 score with high numbers indicating wellbeing and low numbers potentially pain. Aim of our study was to test this monitor in patients after surgery by asking the patients to rate their pain on an established pain scale and noting ANI scores at the same time. We hypothetized that ANI scores would reflect different states of pain with different ANI score results.
Trial website
nil
Trial related presentations / publications
Presented at the Australian Society of Anaesthetists Annual Scientific Meeting in Hobart, Australia 10/12
Public notes

Contacts
Principal investigator
Name 34936 0
Address 34936 0
Country 34936 0
Phone 34936 0
Fax 34936 0
Email 34936 0
Contact person for public queries
Name 18183 0
Prof. Thomas Ledowski
Address 18183 0
Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington Street Campus, Perth WA 6000, Australia
Country 18183 0
Australia
Phone 18183 0
0061-8-9224-1036
Fax 18183 0
0061-8-9224-1111
Email 18183 0
thomas.ledowski@health.wa.gov.au
Contact person for scientific queries
Name 9111 0
Prof. Thomas Ledowski
Address 9111 0
Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital, Wellington Street Campus, Perth WA 6000, Australia
Country 9111 0
Australia
Phone 9111 0
0061-8-9224-1036
Fax 9111 0
0061-8-9224-1111
Email 9111 0
thomas.ledowski@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary