Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000137695
Ethics application status
Approved
Date submitted
31/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain after abdominal surgery study
Scientific title
Predictors of pain after major abdominal surgery
Secondary ID [1] 284020 0
Nil
Universal Trial Number (UTN)
U1111-1152-8516
Trial acronym
PASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal surgery 291058 0
postsurgical pain 291060 0
Condition category
Condition code
Anaesthesiology 291401 291401 0 0
Pain management
Surgery 291402 291402 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A number of clinical, psychological, neurophysiological and genetic variables will be collected preoperatively to ascertain which are significant, independent predictors of acute postoperative pain in the first 14 days after surgery. The predictor variables will be 1. Comorbid Pain - Pain > 2/10 on numerical rating scale (0 = no pain; 10 = worst pain imaginable) that has been present on at least a weekly basis for 1 month or longer. Count number of anatomical locations apart from abdomen where this is true (e.g. n = 3). 2. Pain expectation - measured using the following question "Please indicate the level of pain you think you will experience 1 day after your surgery?" 0-10 Numerical rating scale (0= no pain; 10 = worst pain imaginable)" and 2. Pain expectation - measured using the following question "Please indicate the level of pain you think you will experience 2 weeks after your surgery?" 0-10 Numerical rating scale (0= no pain; 10 = worst pain imaginable)". The average of these scores will be taken. 3. Pain Catastrophising - measured using the Pain Catastrophsing Scale 4. Social support - measured using the Social network index 5. Temporal summation of mechanical pain - assessed through the repetition of 10 standardised punctuate stimuli at a frequency of 1 Hz, applied to an area of the skin 1cm lateral to the planned incision site using a 225.1g Von Frey filament. Patients will be asked to rate the pain intensity of the first and last stimuli on a 0-10 numerical rating scale (0 = no pain; 10 = worst pain imaginable). The difference in pain intensity between the last and first stimuli will be calculated to indicate the magnitude of temporal summation. 6. Conditioned Pain Modulation Efficacy - The electrical stimulation intensity (mA) required to get a pain rating of 60/100 will be measured 1cm lateral to the planned incision site and will be assessed alone (test stimulus) and while the contralateral hand is submerged in cold water (conditioning stimulus). The difference in stimlulation intensities (mA; mean of 2 measures) with and without the conditioning stimulus will be used as a measure of conditioned pain modulation efficacy. 7. Single nucleotide polymorphisms for the Catechol-O-methyl transferase (COMT), mu opiod receptor (OPRM-1), tumor necrosis factor alpha (tnf-alpha); interleukin-1 (IL-1) and interleukin-6 (IL-6) genes - obtained through a single blood sample that will be taken at the same time as routine preoperative bloods. Standard DNA extraction, polymerase chain reaction, microarray and detection methods will be used to identify single nucleotide polymorphisms.
Intervention code [1] 288706 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291393 0
Pain on movement. Numerical pain rating (0-10; 0 = no pain, 10 = worst pain imaginable) in response to sitting upright from a supine position.
Timepoint [1] 291393 0
Sum of pain rating (0-10) from Day 1, Day 2 , Day 7 and Day 14 post surgery
Secondary outcome [1] 306659 0
Pain at rest. Numerical pain rating (0-10; 0 = no pain, 10 = worst pain imaginable) in response to lying still in a supine position for 30 seconds.
Timepoint [1] 306659 0
Sum of pain raitng (0-10) from day 1, day 2, day 7 and day 14 post surgery.

Eligibility
Key inclusion criteria
scheduled to undergo major abdominal surgery at north shore or waitakere hospitals, fluent english speaker and reader.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age; have a diagnosed learning disability; Raynaud's syndrom; are undergoing a palliative procedure; have a loss of normal sensory perception that could interfere with quantitative sensory testing procedures; have a pacemaker fitted.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 5796 0
New Zealand
State/province [1] 5796 0
Auckland

Funding & Sponsors
Funding source category [1] 288644 0
University
Name [1] 288644 0
Health and Rehabilitation Research Institute
Country [1] 288644 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michal Kluger
Address
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country
New Zealand
Secondary sponsor category [1] 287354 0
Individual
Name [1] 287354 0
Dr David Rice
Address [1] 287354 0
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country [1] 287354 0
New Zealand
Secondary sponsor category [2] 287355 0
Individual
Name [2] 287355 0
Dr Matt Soop
Address [2] 287355 0
Dept of General Surgery
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country [2] 287355 0
New Zealand
Other collaborator category [1] 277797 0
Individual
Name [1] 277797 0
Dr Gwyn Lewis
Address [1] 277797 0
Health and Rehabilitation Research Institute
90 Akoranga Drive
Northcote
Auckland
0626
Country [1] 277797 0
New Zealand
Other collaborator category [2] 277798 0
Individual
Name [2] 277798 0
Professor Peter McNair
Address [2] 277798 0
Health and Rehabilitation Research Institute
90 Akoranga Drive
Northcote
Auckland
0626
Country [2] 277798 0
New Zealand
Other collaborator category [3] 277799 0
Individual
Name [3] 277799 0
Dr Elizabeth Broadbent
Address [3] 277799 0
Department of Psychological Medicine
University of Auckland
85 Park Road, Grafton
Auckland
1010
Country [3] 277799 0
New Zealand
Other collaborator category [4] 277800 0
Individual
Name [4] 277800 0
Prof Andrew Somogyi
Address [4] 277800 0
Discipline of Pharmacology
Faculty of Health Sciences, University of Adelaide
Adelaide, 5005, South Australia
Country [4] 277800 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290496 0
Lower South Regional Ethics Committee
Ethics committee address [1] 290496 0
c/- Ministry of Health
229 Moray Place
Dunedin
9016
Ethics committee country [1] 290496 0
New Zealand
Date submitted for ethics approval [1] 290496 0
Approval date [1] 290496 0
15/03/2012
Ethics approval number [1] 290496 0
LRS/11/12/058

Summary
Brief summary
Following abdominal surgery the amount of pain that people experience varies a lot between individuals, despite similar surgical techniques and the same postoperative pain medications. This study will assess people just before their surgery and measure a number of different factors (e.g. pain related beliefs and expectations, individual differences in “pain genes” and “pain sensitivity”). The aim of this study is to see which of these factors can help us predict how much pain someone is likely to experience in the first 14 days after their surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45966 0
Dr Michal Kluger
Address 45966 0
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country 45966 0
New Zealand
Phone 45966 0
+64-9-4861491
Fax 45966 0
Email 45966 0
[email protected]
Contact person for public queries
Name 45967 0
Dr David Rice
Address 45967 0
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country 45967 0
New Zealand
Phone 45967 0
+64-21-430539
Fax 45967 0
Email 45967 0
[email protected]
Contact person for scientific queries
Name 45968 0
Dr David Rice
Address 45968 0
Dept of Anaesthesiology and Perioperative Medicine
North Shore Hospital
121 Shakespeare Road
Milford
Auckland
0620
Country 45968 0
New Zealand
Phone 45968 0
+64-21-430539
Fax 45968 0
Email 45968 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
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Documents added automatically
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