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

Study Overview
=================
Brief 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.

Official Title
-----------------
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial

Conditions
-----------------
Dexamethasone, Hip Dysplasia, Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Dexamethasone 24mg Solution for Injection
* Drug: Saline Solution for Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing PAO due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign) ≥ 18 years Females if fertile: Verified negative human chorionic gonadotropin (HCG), usage of safe contraceptives or surgical sterilisation. Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions. Exclusion Criteria: Patients who cannot speak or understand Danish Allergy or contraindications to trial medication Spinal anaesthesia Second intervention carried out simultaneously (e.g. femur osteotomy) Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted) Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively. Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants) Diabetes diagnosed prior to inclusion Immune suppression therapy (e.g. systemic glucocorticoids) Kidney impairment (eGFR < 50ml/min) or liver disease (≥Child Pugh B)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A; Dexamethasone twice<br>24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours. | Drug: Dexamethasone 24mg Solution for Injection<br>* Administrated i.v.<br>* Other names: Dexa;|
| Experimental: B; Dexamethasone once<br>24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours | Drug: Dexamethasone 24mg Solution for Injection<br>* Administrated i.v.<br>* Other names: Dexa;Drug: Saline Solution for Injection<br>* administrated i.v.<br>* Other names: Saline;|
| Placebo Comparator: C; Placebo twice<br>placebo intravenous just before the operation and repeated after 24 hours | Drug: Saline Solution for Injection<br>* administrated i.v.<br>* Other names: Saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated postoperative morphine consumption in milligrams after 48 hours. | Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg. | 0-48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity after 48 hours. | Pain is evaluated at rest and under the timed-up-and-go (TUG) procedure. Pain intensity is assessed using the visual analogue scale (VAS) (0-100mm). | 24, 48 hours postoperatively | 
| Cumulated postoperative morphine consumption from 48 hours until day 14 post operation | Morphine consumption in milligrams after the operation. | 48 hours - day 14 postoperatively | 
| Postoperative nausea and vomiting | Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe | 24 and 48 hours postoperatively | 
| Antiemetic consumption | Evaluation of cumulated antiemetic consumption in mg and drug will be assessed. | 0-48 hours postoperatively | 
| Sleep | Sleep quality will be assessed using the VAS scale (0-100) | 0-7 days postoperatively | 
| Timed up and go test | Is assessed from; the time that the participant takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. | 24, 48 hours postoperatively | 
| Serious adverse events (SAE) | SAE's including wound infection treated with antibiotics or revision. Patients will be asked for SAE during the intervention period, at a follow-up visit 8 weeks the operation. This will be supplemented with a look up for prescriptions. | 0-8 weeks after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, dexamethasone, pain management