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Trial registered on ANZCTR


Registration number
ACTRN12613000077763
Ethics application status
Approved
Date submitted
31/12/2012
Date registered
21/01/2013
Date last updated
21/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictors of chronic post surgical pain after inguinal hernia surgery
Scientific title
Predictors of chronic post surgical pain after inguinal hernia surgery
Secondary ID [1] 280763 0
None
Universal Trial Number (UTN)
U1111-1132-2533
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Sensory Thresholds 286819 0
Condition category
Condition code
Surgery 287130 287130 0 0
Surgical techniques
Other 287131 287131 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients receive standard analgesic management. Intraoperatively; 40 mg of intravenous parecoxib and intra and postoperative intravenous morphine to be titrated to achieve a numercial rating scale (NRS) pain intensity rating of less than 4 in the post anaesthesia care unit.
Postoperatively; oral sustained release oxycodone of 10 miligrams twice per day plus as required immediate release oxycodone 5 -10 mg every 2 hours if required, together with celecoxib administered at a dose of 200 mg twice per day daily
Pre and post operative (2 months) sensory testing of wind up using electrical stimulation and observation of pain using NRS. Early postoperative measurements will include 24 hour and 7 daily NRS pain intensity ratings and LANSS, weekly NRS pain intensity and LANSS for a total of 8 weeks, as well as opioid and NSAID consumption. The 2 month review will include information regarding pain intensity, opioid, NSAID and other analgesic requirement, short form Brief Pain Inventory questionnaire (BPI), anxiety assessment according to profile of moods scale, Pittsburgh Sleep Quality Index, LANSS and the presence of numbness and allodynia over site of surgery.
Intervention code [1] 285188 0
Not applicable
Comparator / control treatment
Not Applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287446 0
Occurrence of post herniorrhaphy pain at 2 months can be predicted with knowledge of preoperative pain processing integrity testing. We propose to use a testing which predicts wind-up like pain which is based on a technique of quantitative sensory testing. We propose using the RIII reflex, a known pain research tool, as a way of assessing for the presence of, or a higher propensity to develop wind up as it has the advantage of calculating an individualized pain threshold for each subject and then provides summated testing at a level relative to the individualized pain threshold.
Timepoint [1] 287446 0
preoperative and 2 months
Secondary outcome [1] 298163 0
Numerical Rating Scale of Pain (NRS)
Timepoint [1] 298163 0
first 24 hours, daily for 7 days, weekly for 7 week, at 2 months after surgery
Secondary outcome [2] 298630 0
Leeds Assessment of neuropathic symptoms and signs (LANSS)
Timepoint [2] 298630 0
Daily post operative for 7 days, weekly for and including up to 2 months post surgery.
Secondary outcome [3] 298631 0
Area of and intensity of allodynia and hyperalgesia Brush-evoked allodynia will be assessed by lightly stroking the inguinal region of the lower abdominal wall using a brush (SENSELab TM 05, Somedic AB, Sweden) which will be moved from outside the potential site of surgery and converging towards the likely site of the hernia (as indicated by the patient). 12 locations situated in a circle surrounding the likely site of the hernia will be chosen. Once the 12 brush strokes are completed an area of best fit will be drawn and this area will be measured in cm2 as the allodynic area.
Hyperalgesia will be assessed by lightly stroking the inguinal region of the lower abdominal wall using a Von Frey hair in the same manner as assessment for allodynia.
Timepoint [3] 298631 0
Preoperative and 2 months after surgery
Secondary outcome [4] 298632 0
Pittsburgh Sleep Quality Index
Timepoint [4] 298632 0
Preoperative and 2 month after surgery
Secondary outcome [5] 298633 0
Profile of Moods State
Timepoint [5] 298633 0
Preoperative and 2 month after surgery
Secondary outcome [6] 298634 0
Mean opioid consumption converted to oral morphine equivalent as both inpatient and outpatient use. This will be obtained from patient medical records ie. medication chart and a home diary.
Timepoint [6] 298634 0
24 hours post operatively, daily for 7 days, weekly for 7 weeks and 2 months after surgery
Secondary outcome [7] 300455 0
Brief Pain Inventory in Short Form (BPI)
Timepoint [7] 300455 0
Preoperatively and 2 months post surgery
Secondary outcome [8] 300456 0
Demographic data is collected using medical records information and questionaire.
Timepoint [8] 300456 0
preoperatively
Secondary outcome [9] 300457 0
Seniority of surgeon obtained from medical record.
Timepoint [9] 300457 0
Postoperatively
Secondary outcome [10] 300458 0
Operation for hernia after pervious surgery on opposite side obtained from medical record or patient.
Timepoint [10] 300458 0
Preoperatively
Secondary outcome [11] 300459 0
Use and amount of mesh (area) used in hernia repair obtained from medical record operative information.
Timepoint [11] 300459 0
intra/postoperatively
Secondary outcome [12] 300460 0
Visible injury to nerve during hernia repair as speficied in operation report of patient medical record.
Timepoint [12] 300460 0
Intra/postoperatively

Eligibility
Key inclusion criteria
1. Patients who are 18-80 years of age presenting for elective hernia surgery
2. First operation for unilateral inguinal hernia
3. Absence of strangulated or incarcerated tissue in hernial sac.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unable to provide consent
2. Current diagnosis of persistent pain syndrome
3. Current use of opioid medication or tramadol or nonsteroidal antiinflammatories to treat persistent pain
4. Complaint of hernia site pain at rest
5. Allergy or contraindication to use of morphine or oxycodone
6. Allergy or contraindication to use of nonsteroidal antiiflammatories
7. Current use of carbamazepine, phenytoin, sodium valproate, tricyclic antidepressant medications, gabapentin, pregabalin
8. Presence of significant liver impairment (aspartate aminotransferase, alanine aminotransferase, or both >40u/L) or
Presence of significant renal impairment (creatinine >140 micromol/litre)
9. Presence of significant vascular, neurological or dermal disease affecting the upper extremities
10. Presence of uncontrolled hypertension defined by a blood pressure of greater than 150/90 mmHg on screening.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 343 0
The Alfred - Prahran
Recruitment hospital [2] 344 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 5584 0
3181
Recruitment postcode(s) [2] 5585 0
3144

Funding & Sponsors
Funding source category [1] 285763 0
Hospital
Name [1] 285763 0
Alfred Hospital Pain Research Fund
Country [1] 285763 0
Australia
Primary sponsor type
Individual
Name
Dr Alex Konstantatos
Address
c/o Dept. Anaesthesia and Pain Medicine
PO Box 315
Prahran Victoria 3181
Country
Australia
Secondary sponsor category [1] 284592 0
None
Name [1] 284592 0
Address [1] 284592 0
Country [1] 284592 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287774 0
The Alfred Research and Ethics Unit
Ethics committee address [1] 287774 0
Ethics committee country [1] 287774 0
Australia
Date submitted for ethics approval [1] 287774 0
Approval date [1] 287774 0
14/10/2009
Ethics approval number [1] 287774 0
1/09/0301

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34381 0
Dr Alex Konstantatos
Address 34381 0
The Alfred Hospital
c/o Dept. of Anaesthesia and Pain Medicine
PO Box 315
Prahran Victoria 3181
Country 34381 0
Australia
Phone 34381 0
+61390763176
Fax 34381 0
+61390762813
Email 34381 0
a.konstantatos@alfred.org.au
Contact person for public queries
Name 17628 0
Alex Konstantatos
Address 17628 0
The Alfred Hospital
c/o Dept. of Anaesthesia and Pain Medicine
PO Box 315
Prahran Victoria 3181
Country 17628 0
Australia
Phone 17628 0
+61390763176
Fax 17628 0
+61390762813
Email 17628 0
a.konstantatos@alfred.org.au
Contact person for scientific queries
Name 8556 0
Alex Konstantatos
Address 8556 0
The Alfred Hospital
c/o Dept. of Anaesthesia and Pain Medicine
PO Box 315
Prahran Victoria 3181
Country 8556 0
Australia
Phone 8556 0
+61390763176
Fax 8556 0
+61390762813
Email 8556 0
a.konstantatos@alfred.org.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

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