Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000454077
Ethics application status
Approved
Date submitted
27/05/2010
Date registered
3/06/2010
Date last updated
3/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between the numeric rating scale, as a subjective measure of postoperative pain, and the plasma levels of catecholamines
Scientific title
The relationship between the numeric rating scale, as a subjective measure of postoperative pain, and the plasma levels of catecholamines in patients undergoing non-emergency minor surgery
Secondary ID [1] 251881 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute postoperative pain 257478 0
Condition category
Condition code
Anaesthesiology 257629 257629 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of acute pain on a numeric rating scale (NRS 0-10, categories: 0= no pain, 1-3 = mild, 4-5 = moderate, >6 = severe pain) every 5 minutes during a patients stay in the recovery room (as long as this might take) in the recovery room. In addition, monitoring of blood pressure, respiration rate and heart rate, as well as recording and calculation of Electrocardiogram-based parameters of heart rate variability.
At up to 5 time points (admission to the recovery room, discharge from the recovery room + whenever a patient "transits" down a pain category, e.g. from severe to moderate pain, or when a patient "transits" up to any level above "no pain" [no further samples after first "transit up"]) 5 ml blood will be sampled from an intravenous (iv) line sited during the anaesthetic to measure the plasma levels of adrenaline and noradrenaline.
Intervention code [1] 256574 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258540 0
Correlation between acute postoperative pain and stress hormone plasma levels
Timepoint [1] 258540 0
during the stay of a patient in the recovery room (2-5 blood samples, see above)
Secondary outcome [1] 264379 0
Correlation between pain, hormone levels and parameters of heart rate variability, blood pressure and heart rate
Timepoint [1] 264379 0
hormone levels: 2-5 time points, see above
other parameters: approx. 5 minutely during recovery room stay

Eligibility
Key inclusion criteria
age > 18, non-emergency minor surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age < 18, incapacity to consent, pacemaker, any drugs known or suspected to interact with sympathetic tone or haemodynamic parameters (e.g. ketamine, clonidine), chronic drug or alcohol abuse, continuous intravenous opioid infusion

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257070 0
Self funded/Unfunded
Name [1] 257070 0
Country [1] 257070 0
Primary sponsor type
Individual
Name
Thomas Ledowski
Address
Dept. of Anaesthesia, Royal Perth Hospital, Wellington St., Perth WA 6000
Country
Australia
Secondary sponsor category [1] 256328 0
None
Name [1] 256328 0
Address [1] 256328 0
Country [1] 256328 0
Other collaborator category [1] 1307 0
Individual
Name [1] 1307 0
Vimal Kapoor
Address [1] 1307 0
University of Western Australia Pharmacology, M Block QEII Medical Centre, Hospital Ave, Nedlands 6009, WA
Country [1] 1307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259093 0
Royal Perth Hospital
Ethics committee address [1] 259093 0
Ethics Committee of the Royal Perth Hospital, Kirkman House Level 4, Wellington St., Perth WA 6000
Ethics committee country [1] 259093 0
Australia
Date submitted for ethics approval [1] 259093 0
Approval date [1] 259093 0
15/01/2010
Ethics approval number [1] 259093 0
EC 2008/057

Summary
Brief summary
It is commonly believed that acute postoperative pain can lead to an impaired outcome by means of stress hormone provoked physiological changes (e.g. hyperglycaemia, altered immune response, increased myocardial oxygen consumption).
However, it has not yet been investigated whether or not pain that is often measured by means of subjective pain scales (e.g. numeric rating scale, NRS) actually correlates with changes in the plasma level of stress hormones.

Aim of this study is to investigate the relationship between the subjective NRS score (0-10; 0= no pain, 10 = worst pain) and the plasma levels of adrenaline and noradrenaline. Furthermore, the correlation between these parameters and other non-invasive measures of pain (heart rate [HR], blood pressure [BP], respiration rate [RR], heart rate variability [HRV]) will be investigated.

For this purpose, 85 patients scheduled for non-emergency plastic surgery will be included in the trial. On arrival in the recovery room, 4 ml blood will be taken from a cannula sited during the anaesthetic into the cubital fossa to measure plasma levels of catecholamines. Simultaneously, HR, BP and RR will be recorded as part of the recovery room protocol and the patient will be asked to rate their pain on the NRS. In addition, data from the connected electrocardiogram will be downloaded onto a laptop PC to calculate parameters of HRV by means of the MEMCALC method: total power, low frequency, high frequency, the low: high frequency ratio and a non-linear approach, ultra-short entropy. These HRV parameters are purely mathematical calculations (hence “no touch” technique) and have previously shown correlations with the sympatho-vagal balance.

At the time of discharge from the recovery unit, above mentioned procedure will be repeated. In between these 2 time points, the procedure may be repeated up to 3 times if a patient “moves” from one pain category into another (4 categories defined: no [NRS 0], mild [NRS 1-3], moderate [NRS 4-5] and severe [NRS 6-10] pain). To identify changes in pain perception, patients are frequently (approx. 5 minutely) asked to rate their pain on the NRS. This is a standard procedure in the Royal Perth Hospital recovery room.

Hence, a minimum of 2 and a maximum of 5 blood samples (=20ml) may be taken of a subject.

The study period ends with discharge of a patient from the recovery room.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 31233 0
Address 31233 0
Country 31233 0
Phone 31233 0
Fax 31233 0
Email 31233 0
Contact person for public queries
Name 14480 0
Prof. Thomas Ledowski
Address 14480 0
Dept. of Anaesthesia, Royal Perth Hospital, Wellington St., Perth WA 6000
Country 14480 0
Australia
Phone 14480 0
0061 8 9224 1037
Fax 14480 0
0061 8 9224 1111
Email 14480 0
[email protected]
Contact person for scientific queries
Name 5408 0
Prof. Thomas Ledowski
Address 5408 0
Dept. of Anaesthesia, Royal Perth Hospital, Wellington St., Perth WA 6000
Country 5408 0
Australia
Phone 5408 0
0061 8 9224 1037
Fax 5408 0
Email 5408 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
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