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

NCT03874936 | Completed Phase 2 DMC

• 2 other identifiers: SO_SH_01_20192019_000402_30
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

postoperative pain; dexamethasone; pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  0-48 hours postoperatively

Secondary Outcomes (7)

• Postoperative pain intensity after 48 hours.

  24, 48 hours postoperatively

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

  48 hours - day 14 postoperatively

• Postoperative nausea and vomiting

  24 and 48 hours postoperatively

• Antiemetic consumption

  0-48 hours postoperatively

• Sleep

  0-7 days postoperatively

Other Outcomes (9)

• Cumulated postoperative morphine consumption in milligrams after 24hours.

  0-24 hours postoperatively

• Cumulated antiemetic consumption

  0-24 hours postoperatively

• Fasting blood glucose

  0 hours, 6 hours, 24 hours, 48 hours (72 hours)

Study Arms (3)

A; Dexamethasone twice

EXPERIMENTAL

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

Drug: Dexamethasone 24mg Solution for Injection

B; Dexamethasone once

EXPERIMENTAL

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

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

C; Placebo twice

PLACEBO COMPARATOR

placebo intravenous just before the operation and repeated after 24 hours

Drug: Saline Solution for Injection

Interventions

Dexamethasone 24mg Solution for Injection DRUG

Administrated i.v.

Also known as: Dexa

A; Dexamethasone twice; B; Dexamethasone once

Saline Solution for Injection DRUG

administrated i.v.

Also known as: Saline

B; Dexamethasone once; C; Placebo twice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Immune suppression therapy (e.g. systemic glucocorticoids)
• Kidney impairment (eGFR \< 50ml/min) or liver disease (≥Child Pugh B)

Sponsors & Collaborators

• Odense University Hospital: lead
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Lindberg-Larsen V, Lindberg-Larsen M, Ovesen O, Zwisler ST, Lindholm P, Hebsgaard S, Christensen R, Overgaard S. Effect of high-dose dexamethasone on morphine use after periacetabular osteotomy for hip dysplasia: a randomized double-blind placebo-controlled single center trial. Acta Orthop. 2025 Jun 1;96:413-420. doi: 10.2340/17453674.2025.43903.

  PMID: 40460271 DERIVED

MeSH Terms

Conditions

Hip Dislocation; Pain, Postoperative; Postoperative Nausea and Vomiting; Agnosia

Interventions

Dexamethasone; Solutions; Injections; Absorptiometry, Photon; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Viktoria Lindberg-Larsen, MD, PhD

  Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, principal investigator and sponsor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 14, 2019
• Study Start: November 12, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)