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

Odense University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain; Hip Dysplasia; Postoperative Nausea and Vomiting; Dexamethasone

Treatments: Drug: Dexamethasone 24mg Solution for Injection; Drug: Saline Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03874936

SO_SH_01_2019

2019_000402_30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

A; Dexamethasone twice

Experimental group

Description:

24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.

Treatment:

Drug: Dexamethasone 24mg Solution for Injection

B; Dexamethasone once

Experimental group

Description:

24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours

Treatment:

Drug: Saline Solution for Injection

Drug: Dexamethasone 24mg Solution for Injection

C; Placebo twice

Placebo Comparator group

Description:

placebo intravenous just before the operation and repeated after 24 hours

Treatment:

Drug: Saline Solution for Injection