Clinical trial NCT03874936: The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
Official title: The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dexamethasone
Hip Dysplasia
Postoperative Pain
Postoperative Nausea and Vomiting
Keywords: postoperative pain
dexamethasone
pain management
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
First posted: 2019-03-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Cumulated postoperative morphine consumption in milligrams after 48 hours.
timeFrame: 0-48 hours postoperatively
Secondary outcomes:
measure: Postoperative pain intensity after 48 hours.
timeFrame: 24, 48 hours postoperatively
measure: Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
timeFrame: 48 hours - day 14 postoperatively
measure: Postoperative nausea and vomiting
timeFrame: 24 and 48 hours postoperatively
measure: Antiemetic consumption
timeFrame: 0-48 hours postoperatively
measure: Sleep
timeFrame: 0-7 days postoperatively
measure: Timed up and go test
timeFrame: 24, 48 hours postoperatively
measure: Serious adverse events (SAE)
timeFrame: 0-8 weeks after operation
Other outcomes:
measure: Cumulated postoperative morphine consumption in milligrams after 24hours.
timeFrame: 0-24 hours postoperatively
measure: Cumulated antiemetic consumption
timeFrame: 0-24 hours postoperatively
measure: Fasting blood glucose
timeFrame: 0 hours, 6 hours, 24 hours, 48 hours (72 hours)
measure: C-reactive protein (CRP)
timeFrame: 0, 6, 24, 48 hours (72 hours) postoperatively
measure: Leucocytes
timeFrame: 0, 6, 24, 48 hours (72 hours) postoperatively
measure: Cytokines
timeFrame: 0, 6, 24, 48 hours (72 hours) postoperatively
measure: Patient reported outcome measure, quality of life
timeFrame: 3, 6, 12 months postoperatively
measure: Patient reported outcome measures, health
timeFrame: 3, 6, 12 months postoperatively
measure: Patient reported outcome measures, the Oxford Hip questionnaire
timeFrame: 3, 6, 12 months postoperatively
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital
name: Viktoria Lindberg-Larsen, MD, PhD
role: STUDY_CHAIR
References: