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

Phase 2

Completed

Conditions: Dexamethasone
Hip Dysplasia
Postoperative Nausea and Vomiting
Postoperative Pain

Interventions: Drug: Dexamethasone 24mg Solution for Injection
Drug: Saline Solution for Injection

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
A; Dexamethasone twice	Dexamethasone 24mg Solution for Injection	24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.
B; Dexamethasone once	Saline Solution for Injection	24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
C; Placebo twice	Saline Solution for Injection	placebo intravenous just before the operation and repeated after 24 hours
B; Dexamethasone once	Dexamethasone 24mg Solution for Injection	24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation	48 hours - day 14 postoperatively	Morphine consumption in milligrams after the operation.
Postoperative pain intensity after 48 hours.	24, 48 hours postoperatively	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).
Postoperative nausea and vomiting	24 and 48 hours postoperatively	Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe
Antiemetic consumption	0-48 hours postoperatively	Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.
Sleep	0-7 days postoperatively	Sleep quality will be assessed using the VAS scale (0-100)
Timed up and go test	24, 48 hours postoperatively	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.
Serious adverse events (SAE)	0-8 weeks after operation	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.