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

Odense University Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Dexamethasone Hip Dysplasia Postoperative Pain Postoperative Nausea and Vomiting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 0-48 hours postoperatively

Secondary Outcomes

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).

Time frame: 24, 48 hours postoperatively

Cumulated postoperative morphine consumption from 48 hours until day 14 post operation

Morphine consumption in milligrams after the operation.

Time frame: 48 hours - day 14 postoperatively

Postoperative nausea and vomiting

Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe

Time frame: 24 and 48 hours postoperatively

Antiemetic consumption

Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.

Time frame: 0-48 hours postoperatively

Sleep

Sleep quality will be assessed using the VAS scale (0-100)

Time frame: 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.

Time frame: 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.

Time frame: 0-8 weeks after operation