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

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Collaborator: Odense Patient Data Explorative Network
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions

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)