None listed
Conditions
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.
Interventions
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 concent
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.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Undergoing surgical correction of hallux valgus facilitated through the UWA Podiatric Surgery Clinic 2. Aged 18 years or older
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
Outcome results
None listed