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NCT Number: NCT03874936

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone 24mg Solution for Injection

Drug

Administrated i.v.

Other names: Dexa

Saline Solution for Injection

Drug

administrated i.v.

Other names: Saline

Primary outcomes

  1. Cumulated postoperative morphine consumption in milligrams after 48 hours.

    Time frame: 0-48 hours postoperatively

    Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.

Secondary outcomes

  1. Postoperative pain intensity after 48 hours.

    Time frame: 24, 48 hours postoperatively

    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).

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

    Time frame: 48 hours - day 14 postoperatively

    Morphine consumption in milligrams after the operation.

  3. Postoperative nausea and vomiting

    Time frame: 24 and 48 hours postoperatively

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

  4. Antiemetic consumption

    Time frame: 0-48 hours postoperatively

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

  5. Sleep

    Time frame: 0-7 days postoperatively

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

  6. Timed up and go test

    Time frame: 24, 48 hours postoperatively

    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.

  7. Serious adverse events (SAE)

    Time frame: 0-8 weeks after operation

    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.

Other outcomes

  1. Cumulated postoperative morphine consumption in milligrams after 24hours.

    Time frame: 0-24 hours postoperatively

    Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.

  2. Cumulated antiemetic consumption

    Time frame: 0-24 hours postoperatively

    antiemetic consumption in mg and drug will be assessed after 24hrs.

  3. Fasting blood glucose

    Time frame: 0 hours, 6 hours, 24 hours, 48 hours (72 hours)

    assessment of fasting blood glucose in mg/mL

  4. C-reactive protein (CRP)

    Time frame: 0, 6, 24, 48 hours (72 hours) postoperatively

    blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.

  5. Leucocytes

    Time frame: 0, 6, 24, 48 hours (72 hours) postoperatively

    blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development.

  6. Cytokines

    Time frame: 0, 6, 24, 48 hours (72 hours) postoperatively

    evaluate the decrease of cytokines concentration (Interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF) and pentraxin 3 (PTX3) as markers of response during treatment with Dexamethasone

  7. Patient reported outcome measure, quality of life

    Time frame: 3, 6, 12 months postoperatively

    Based on the questionnaire: EuroQol - 5 Dimensions (EQ-5D) after 3 and 6 months and 1 year follow up.

  8. Patient reported outcome measures, health

    Time frame: 3, 6, 12 months postoperatively

    Patient evaluated health based on the questionnaire: University of California, Los Angeles (UCLA) after 3 and 6 months and 1 year follow up.

  9. Patient reported outcome measures, the Oxford Hip questionnaire

    Time frame: 3, 6, 12 months postoperatively

    Patient evaluated activity and pain, based on the questionnaire: Oxford Hip after 3 and 6 months and 1 year follow up.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Odense Patient Data Explorative Network

Registry information

Official study title

The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial

Acronym: PAODEX

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 14, 2019
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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