ANZCTR - Registration

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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

Condition category

Condition code

Skin

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]

None

Comparator / control treatment

No comparator.

Control group

Outcomes

Primary outcome [1]

Correlation between postoperative pain and skin conductance measures at several time points in the recovery period

Timepoint [1]

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]

Correation between administration of analgetic drugs and skin conductance.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Dept. of Anaesthesia and Pain Medicine, Royal Perth Hospital

Address [1]

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Thomas Ledowski

Address

Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000

Country

Australia

Phone

+61 8 92241036

Fax

thomas.ledowski@health.wa.gov.au

Contact person for scientific queries

Name

Dr. Thomas Ledowski

Address

Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000

Country

Australia

Phone

+61 8 92241036

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

No additional documents have been identified.

Trial Review

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