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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dexamethasone Hip Dysplasia Postoperative Pain Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A; Dexamethasone twice

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

Group Type EXPERIMENTAL

Dexamethasone 24mg Solution for Injection

Intervention Type DRUG

Administrated i.v.

B; Dexamethasone once

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

Group Type EXPERIMENTAL

Dexamethasone 24mg Solution for Injection

Intervention Type DRUG

Administrated i.v.

Saline Solution for Injection

Intervention Type DRUG

administrated i.v.

C; Placebo twice

placebo intravenous just before the operation and repeated after 24 hours

Group Type PLACEBO_COMPARATOR

Saline Solution for Injection

Intervention Type DRUG

administrated i.v.

Interventions

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Dexamethasone 24mg Solution for Injection

Administrated i.v.

Intervention Type DRUG

Saline Solution for Injection

administrated i.v.

Intervention Type DRUG

Other Intervention Names

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Dexa Saline

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No