ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-operative pain management

Hallux valgus

Condition category

Condition code

Anaesthesiology

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]

Treatment: Drugs

Intervention code [2]

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]

Time to post-operative analgesic medication assessed through logbook documentation

Timepoint [1]

When patient has a pain score of 3/10 or greater

Primary outcome [2]

Pain intensity and interference assessed through the use of Brief Pain Inventory-Short Form (BPI-sf)

Timepoint [2]

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]

Proportion of participants that received post-operative analgesic medication within each treatment group as assessed through logbook documentation

Timepoint [1]

14 days after the end of the surgery

Secondary outcome [2]

Total post-operative analgesic consumption assessed through logbook documentation and pill count (the number of pills dispensed – the number of pills counted)

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

24/03/2014

Actual

25/04/2014

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]

University

Name [1]

University of Western Australia Podiatric Medicine Unit

Address [1]

M422, Cnr Park Ave and Crawley Ave, Crawley WA 6009

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

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

A/Prof Reza Naraghi

Address

The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009

Country

Australia

Phone

61864884526

Fax

61864884525

[email protected]

Contact person for public queries

Name

Reza Naraghi

Address

The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009

Country

Australia

Phone

61864884526

Fax

[email protected]

Contact person for scientific queries

Name

Reza Naraghi

Address

The University of Western Australia
Crn of Park Ave and Crawley Ave
Crawley WA 6009

Country

Australia

Phone

61864884526

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Ongzalima, C. O., Lee, W. L. R., Hoang, A., Wong, ... [More Details]	366849-(Uploaded-22-07-2019-16-13-34)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically