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Trial registered on ANZCTR


Trial ID
ACTRN12614000860662
Ethics application status
Approved
Date submitted
4/08/2014
Date registered
11/08/2014
Date last updated
11/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-operative analgesic efficacy of dexamethasone sodium phosphate versus triamcinolone acetonide in bunionectomy: A prospective, single-blinded pilot randomized controlled trial
Scientific title
Post-operative analgesic efficacy of dexamethasone sodium phosphate versus triamcinolone acetonide in bunion surgery: A prospective, single-blinded randomized controlled trial
Secondary ID [1] 285106 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain management 292657 0
Hallux valgus 292658 0
Condition category
Condition code
Anaesthesiology 292973 292973 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to their surgery, all consenting participants will require to complete a demographic questionnaire. Participants will be randomly assigned to a single-blind pre-operative administration from coded ampoules of either 4mg dexamethasone sodium phosphate (DBL Dexamethasone sodium phosphate 4mg/mL) or 10mg of triamcinolone acetonide (Kenacort - Registered Trademark -A 10 10mg/mL). The administration of all corticosteroids will be done in combination with 5mL of Naropeine to prevent high concentration damage to the soft tissues. The amount to be injected will be divided equally and infiltrated on the dorsal, medial, plantar and lateral aspects of the first metatarsal, in a Mayo block fashion proximal to the surgical site. The dose injected is based upon previous experiences of the podiatric surgeon and falls within the recommended dose ranges for soft tissue corticosteroid injections. Participants will then proceed to have the hallux valgus surgery performed as planned. All procedures of the surgery would follow the standard UWA hallux valgus protocol.

After the procedure, all patients will have their dressings applied uniformly by the same surgeon. This is important to eliminate the risk of increased postoperative pain secondary to a tighter bandage on one patient than on the other. All patients will also receive postoperative analgesic medication (Prodeine - Registered Trademark 15 tablets) as part of UWA Podiatric Surgery Clinic’s standard post-operative care procedure. A logbook and a self-administered Brief Pain Inventory short form (BPI-sf) questionnaire will also be given to the participants to document the pain outcomes of the injections.
Intervention code [1] 289953 0
Treatment: Drugs
Intervention code [2] 289954 0
Prevention
Comparator / control treatment
Active control: Standard treatment
Name of drug: Dexamethasone sodium phosphate (DBLTM Dexamethasone sodium phosphate)
Dose: 4mg/mL
Duration: Once, done pre-operatively
Mode of administration: Soft tissue injection
Control group
Active

Outcomes
Primary outcome [1] 292827 0
Time to post-operative analgesic medication assessed through logbook documentation
Timepoint [1] 292827 0
When patient has a pain score of 3/10 or greater
Primary outcome [2] 292828 0
Pain intensity and interference assessed through the use of Brief Pain Inventory-Short Form (BPI-sf)
Timepoint [2] 292828 0
Either immediately prior to receiving post-operative analgesic medication or 14 days after the end of the surgery if patient does not require any medication

The outcome is assessed only at one timepoint. Completing the BPI-sf immediately prior to receiving medications would allow assessment of the patient's pain intensity at its most intolerable state (pain score of 3/10 or greater). Patient would then consume the medication to relieve the pain.

Patients who do not need to consume any medications (pain score of 2/10 or lesser) would then complete the BPI-sf 14 days after the surgery, indicating no pain or slight pain that do not require consumption of any medication.
Secondary outcome [1] 309764 0
Proportion of participants that received post-operative analgesic medication within each treatment group as assessed through logbook documentation
Timepoint [1] 309764 0
14 days after the end of the surgery
Secondary outcome [2] 309765 0
Total post-operative analgesic consumption assessed through logbook documentation and pill count (the number of pills dispensed – the number of pills counted)
Timepoint [2] 309765 0
14 days after the end of the surgery

Eligibility
Key inclusion criteria
1. Undergoing surgical correction of hallux valgus facilitated through the UWA Podiatric Surgery Clinic
2. Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment, intellectual disability, physical disability or mental illness
2. Allergy/ hypersensitivity to any corticosteroids
3. Systemic viral and fungal infections
4. Allergy/ hypersensitivity to Prodeine - Registered Trademark 15
5. Diabetes mellitus, inflammatory arthritis and any other forms of immunodeficiency
6. Currently taking medications that can interact with dexamethasone sodium phosphate or triamcinolone acetonide

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study population will comprise of subjects that are scheduled for the correction of hallux valgus at the UWA Podiatric Surgery Clinic. Participants will be recruited
prospectively through a volunteer sampling method following standard protocol for preoperative assessment at the clinic. Only subjects who register
interest in the study and fulfill all inclusion and exclusion criteria will be recruited by the research investigators.

Subjects who are eligible for inclusion in the study will be informed of the availability of study by the attending podiatric surgeon. They will be asked to contact the chief investigator, Associate professor Reza Naraghi via email requesting they be contacted regarding participation into the study. Interested subjects will be provided with verbal information about the research as well as a written participant information sheet. Informed consent will be obtained from all willing participants of the study prior to the intervention process, which involves randomization to either dexamethasone sodium phosphate or triamcinolone acetonide. All communications with participants thereafter will be made through the UWA Podiatric Surgery Clinic.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to receive either dexamethasone sodium phosphate (4 mg/ml) or triamcinolone acetonide (10 mg/ml). Stratified randomization of participants will be conducted prior to the surgery using computer generated lists to ensure equal allocation of participants with differing prognostic factors to each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
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)
WA

Funding & Sponsors
Funding source category [1] 289713 0
University
Name [1] 289713 0
University of Western Australia Podiatric Medicine Unit
Address [1] 289713 0
M422, Cnr Park Ave and Crawley Ave, Crawley WA 6009
Country [1] 289713 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
M422, Cnr Park Ave and Crawley Ave, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 288407 0
None
Name [1] 288407 0
Address [1] 288407 0
Country [1] 288407 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Patients recovering from surgical procedures generally require pharmacotherapy to assist in post-operative pain management. Corticosteroids are anti-inflammatory agents often administered in their injectable form by podiatric surgeons during pre-operative analgesia in order to assist in reducing post-operative inflammation and pain associated with foot surgery. Despite their wide anecdotal application in podiatric practice, there are few studies supporting the use of injectable corticosteroids for this purpose, and no guidelines presently exist in regards to appropriate drug or dosage selection. A prospective, single-blind randomized controlled-trial will be conducted to demonstrate and compare the efficacy of short-acting dexamethasone sodium phosphate versus intermediate-acting triamcinolone acetonide in participants undergoing a surgical procedure to correct hallux valgus, facilitated through The
University of Western Australia Podiatric Surgery Clinic. This study aims to investigate and compare the efficacy of the two different corticosteroids in post-operative pain management, assessed over a 14-day period through 4 end points: Brief Pain Inventory short form, time to post-operative analgesic medication, post-operative analgesic consumption and proportion of participants within each group that received post-operative analgesic medication. We hypothesized that injectable triamcinolone acetonide is more effective in reducing post-operative pain than dexamethasone sodium phosphate, following hallux valgus surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50454 0
A/Prof Reza Naraghi
Address 50454 0
The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009
Country 50454 0
Australia
Phone 50454 0
61864884526
Fax 50454 0
61864884525
Email 50454 0
reza.naraghi@uwa.edu.au
Contact person for public queries
Name 50455 0
A/Prof Reza Naraghi
Address 50455 0
The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009
Country 50455 0
Australia
Phone 50455 0
61864884526
Fax 50455 0
Email 50455 0
reza.naraghi@uwa.edu.au
Contact person for scientific queries
Name 50456 0
A/Prof Reza Naraghi
Address 50456 0
The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009
Country 50456 0
Australia
Phone 50456 0
61864884526
Fax 50456 0
Email 50456 0
reza.naraghi@uwa.edu.au