The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
Summary
This is an investigator-initiated, Danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (PAO). 90 adults undergoing PAO will be enrolled. The primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours. Key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: Perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.
Timeline
- Start
- 2020-11-12
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
Outcome
Missed primary endpoint
paper corresponding to a between-group difference of -3 mg (95% confidence interval -27 to 21; P = 0.8). PMID 40460271 ↗
paper High-dose dexamethasone did not reduce postoperative morphine use or improve any of the secondary outcomes after PAO. PMID 40460271 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 24 mg | Intravenous |