MedTrace Logo

The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.

NCT03874936 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Dexamethasone
  • Hip Dysplasia
  • Postoperative Pain
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Dexamethasone 24mg Solution for Injection

Administrated i.v.

DRUG

Saline Solution for Injection

administrated i.v.

Sponsors & Collaborators

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Viktoria Lindberg-Larsen, MD, PhD · Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874936 on ClinicalTrials.gov