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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03874936
Other study ID # SO_SH_01_2019
Secondary ID 2019_000402_30
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 12, 2020
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone 24mg Solution for Injection
Administrated i.v.
Saline Solution for Injection
administrated i.v.

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (2)

Lead Sponsor Collaborator
Odense University Hospital Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Cumulated postoperative morphine consumption in milligrams after 24hours. Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg. 0-24 hours postoperatively
Other Cumulated antiemetic consumption antiemetic consumption in mg and drug will be assessed after 24hrs. 0-24 hours postoperatively
Other Fasting blood glucose assessment of fasting blood glucose in mg/mL 0 hours, 6 hours, 24 hours, 48 hours (72 hours)
Other C-reactive protein (CRP) blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development. 0, 6, 24, 48 hours (72 hours) postoperatively
Other Leucocytes blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development. 0, 6, 24, 48 hours (72 hours) postoperatively
Other Cytokines 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 0, 6, 24, 48 hours (72 hours) postoperatively
Other Patient reported outcome measure, quality of life Based on the questionnaire: EuroQol - 5 Dimensions (EQ-5D) after 3 and 6 months and 1 year follow up. 3, 6, 12 months postoperatively
Other Patient reported outcome measures, health Patient evaluated health based on the questionnaire: University of California, Los Angeles (UCLA) after 3 and 6 months and 1 year follow up. 3, 6, 12 months postoperatively
Other Patient reported outcome measures, the Oxford Hip questionnaire Patient evaluated activity and pain, based on the questionnaire: Oxford Hip after 3 and 6 months and 1 year follow up. 3, 6, 12 months postoperatively
Primary 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 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). 24, 48 hours postoperatively
Secondary Cumulated postoperative morphine consumption from 48 hours until day 14 post operation Morphine consumption in milligrams after the operation. 48 hours - day 14 postoperatively
Secondary Postoperative nausea and vomiting Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe 24 and 48 hours postoperatively
Secondary Antiemetic consumption Evaluation of cumulated antiemetic consumption in mg and drug will be assessed. 0-48 hours postoperatively
Secondary Sleep Sleep quality will be assessed using the VAS scale (0-100) 0-7 days postoperatively
Secondary 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. 24, 48 hours postoperatively
Secondary 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. 0-8 weeks after operation
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