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| ID | Type | Description | Link |
|---|---|---|---|
| 2019_000402_30 | EudraCT Number |
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| Name | Class |
|---|---|
| Odense Patient Data Explorative Network | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A; Dexamethasone twice | Experimental | 24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours. |
|
| 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 |
|
| C; Placebo twice | Placebo Comparator | placebo intravenous just before the operation and repeated after 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 24mg Solution for Injection | Drug | Administrated i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulated postoperative morphine consumption from 48 hours until day 14 post operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cumulated antiemetic consumption |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viktoria Lindberg-Larsen, MD, PhD | Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40460271 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Mar 31, 2024 |
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| Saline Solution for Injection | Drug | administrated i.v. |
|
|
Morphine consumption in milligrams after the operation. |
| 48 hours - day 14 postoperatively |
| Postoperative nausea and vomiting | Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe | 24 and 48 hours postoperatively |
| Antiemetic consumption | Evaluation of cumulated antiemetic consumption in mg and drug will be assessed. | 0-48 hours postoperatively |
| Sleep | Sleep quality will be assessed using the VAS scale (0-100) | 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. | 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. | 0-8 weeks after operation |
antiemetic consumption in mg and drug will be assessed after 24hrs. |
| 0-24 hours postoperatively |
| Fasting blood glucose | assessment of fasting blood glucose in mg/mL | 0 hours, 6 hours, 24 hours, 48 hours (72 hours) |
| 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 |
| Leucocytes | blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development. | 0, 6, 24, 48 hours (72 hours) postoperatively |
| 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 |
| 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 |
| 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 |
| 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 |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012996 | Solutions |
| D007267 | Injections |
| D015502 | Absorptiometry, Photon |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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