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Steroids for Pain Management in Total Knee Arthroplasty
NCT03901768Phase 4
Key facts
- Status
- Unknown
- Start
- Apr 2018
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- The University of Hong Kong
- Modality
- Orthosteric Ligands
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial of dexamethasone and triamcinolone in postoperative pain (4 arms), sponsored by The University of Hong Kong. Primary endpoints: Pain (rest, moment), PCA morphine consumption and 2 more. Status: unknown.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Group dexamethasone
IV Dexamethasone (16mg)
Group triamcinolone
Intra-articular Triamcinolone (40mg)
Group dexamethasone with triamcinolone
IV Dexamethasone (16mg) + Intra-articular Triamcinolone (40mg)
Placebo group
IV Saline + Intra-articular Saline
03
Who it enrols
Adult Chinese patients (18-80 years) scheduled for elective primary unilateral total knee replacement, able to speak Cantonese. Excludes patients with revision/bilateral TKA, chronic pain, insulin-dependent diabetes, hepatitis B/C, peptic ulcer, tuberculosis, immunosuppression, daily steroid/opioid use, severe heart disease (NYHA 2), renal impairment (>120 micromol/L), or pregnancy.
04
Endpoints
Primary
Pain (rest, moment)
PCA morphine consumption
Active and passive Range of Motion of knee
Local Knee function e.g. KSKS
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