Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000166572
Ethics application status
Approved
Date submitted
28/04/2006
Date registered
10/05/2006
Date last updated
10/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring of Skin Conductance to Assess Postoperative Pain Intensity
Scientific title
Non-randomized, observational trial to assess correlations between skin conductance and postoperative pain in the recovery room
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 1139 0
Condition category
Condition code
Skin 1219 1219 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention; we will observe the changes in skin conductance (measured by 3 electrodes at the palmar surface of the hand) in the postoperative period (meanwhile the patient is in the recovery room, so for approximately about 20 to 120 minutes) and its correlation with postoperative pain. Each single measurement will take approximately 10 seconds.
Intervention code [1] 1008 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1654 0
Correlation between postoperative pain and skin conductance measures at several time points in the recovery period
Timepoint [1] 1654 0
On arrival, every 2 minutes until pain free according to a patient's pain self-assessement numeric rating scale (NRS). Once pain free, the patients asked to rate their pain again after 10 min - Skin conductance will be recorded at this time as well.
Secondary outcome [1] 2949 0
Correation between administration of analgetic drugs and skin conductance.
Timepoint [1] 2949 0
Skin conductance will be measured before an analgetic drug is given and 2 minutes afterwards.

Eligibility
Key inclusion criteria
Patients > 18 yrs, male and female patients.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pacemaker, betavlocker, atropine/glycopyrrolate medication, inability to communicate in English.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1330 0
Hospital
Name [1] 1330 0
Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital
Country [1] 1330 0
Australia
Primary sponsor type
Individual
Name
Dr. Thomas Ledowski
Address
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Country
Australia
Secondary sponsor category [1] 1174 0
None
Name [1] 1174 0
Nil
Address [1] 1174 0
Country [1] 1174 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Previous investigations have shown that a relatively new method of skin conductance assessment (SC) correlates with periods of stress and pain (one of which might be during the period of recovery after anaesthesia) during an operation. The method follows the “lie detector principle”: the electric skin conductance is assessed by three self-sticking electrodes placed on the palm of the hand. People who are stressed often experience “sweaty palms” (due to changes in the autonomous nervous system that results in an increased filling of sweat glands). The wetter the palms, the higher the skin conductance recorded.
We would like to compare the method of SCA to the results of score based pain assessment, like a visual analogue scale, during the recovery period after general anaesthesia.

In this study we will recruit 75 patients. The patients will receive a standard anaesthesia and postoperative care. The SCA uses three ECG electrodes placed on the palmar surface of the hand. It is safe and not painful.
We will not interfere with the anaesthesia or postoperative pain control in any way, but will observe the monitored data to get an idea about how well it correlates with our normal score based pain assessment. For that purpose, a nurse who is blinded to the readings of the skin conductance monitor will ask the patient to rate his pain on a numeric rating scale (0-10), as normally done to rate a patient's pain level in the recovery room. A second observer will record the results from the monitor ast the same time.
The study will hopefully help to develop a better monitoring device for the assessment of postoperative pain. This might help with patients who have difficulties in expression of pain, for example, due to language problems or confusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35698 0
Address 35698 0
Country 35698 0
Phone 35698 0
Fax 35698 0
Email 35698 0
Contact person for public queries
Name 10197 0
Dr. Thomas Ledowski
Address 10197 0
Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 10197 0
Australia
Phone 10197 0
+61 8 92241036
Fax 10197 0
Email 10197 0
[email protected]
Contact person for scientific queries
Name 1125 0
Dr. Thomas Ledowski
Address 1125 0
Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 1125 0
Australia
Phone 1125 0
+61 8 92241036
Fax 1125 0
Email 1125 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
No additional documents have been identified.