Dexamethasone, Hip Dysplasia, Postoperative Pain, Postoperative Nausea and Vomiting
Conditions
Keywords
postoperative pain, dexamethasone, pain management
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.
Interventions
DRUGDexamethasone 24mg Solution for Injection
Administrated i.v.
administrated i.v.
Sponsors
Odense Patient Data Explorative Network
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulated postoperative morphine consumption in milligrams after 48 hours. | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulated postoperative morphine consumption from 48 hours until day 14 post operation | 48 hours - day 14 postoperatively | Morphine consumption in milligrams after the operation. |
| Postoperative nausea and vomiting | 24 and 48 hours postoperatively | Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe |
| Antiemetic consumption | 0-48 hours postoperatively | Evaluation of cumulated antiemetic consumption in mg and drug will be assessed. |
| Postoperative pain intensity after 48 hours. | 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). |
| Timed up and go test | 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. |
| Serious adverse events (SAE) | 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. |
| Sleep | 0-7 days postoperatively | Sleep quality will be assessed using the VAS scale (0-100) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulated postoperative morphine consumption in milligrams after 24hours. | 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. |
| Patient reported outcome measures, the Oxford Hip questionnaire | 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. |
| Cumulated antiemetic consumption | 0-24 hours postoperatively | antiemetic consumption in mg and drug will be assessed after 24hrs. |
| Fasting blood glucose | 0 hours, 6 hours, 24 hours, 48 hours (72 hours) | assessment of fasting blood glucose in mg/mL |
| C-reactive protein (CRP) | 0, 6, 24, 48 hours (72 hours) postoperatively | blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development. |
| Leucocytes | 0, 6, 24, 48 hours (72 hours) postoperatively | blood sample to evaluate the influence of dexamethasone on the postoperative inflammation development. |
| Cytokines | 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 |
| Patient reported outcome measure, quality of life | 3, 6, 12 months postoperatively | Based on the questionnaire: EuroQol - 5 Dimensions (EQ-5D) after 3 and 6 months and 1 year follow up. |
| Patient reported outcome measures, health | 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. |
Countries
Denmark
Outcome results
None listed