drugset / Trial / NCT02767882

Dexamethasone in Pain Control After Total Knee Replacement

NCT02767882 ↗

Phase 4 Completed 138 enrolled The University of Hong Kong
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens. Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. It is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.

Timeline

Start
2016-05-01
Primary completion
2019-01-31
Completion
2020-12-31

Outcome

Met primary endpoint

paper Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3 [-1.3 (95% CI, -2.2 to -0.31), P = 0.005]. PMID 33105245 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Intravenous
Subject Dexamethasone Small molecule 16 mg Intravenous

Indications

No indication recorded.