DexamethasonePhase 2/3PAODEXNCT03874936
The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy.
A Phase 2/3 study testing Dexamethasone 24mg Solution for Injection and Saline Solution for Injection in people with Dexamethasone and Hip Dysplasia, run by Odense University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexamethasone, Hip Dysplasia, Postoperative Pain
- What is being tested?
- Dexamethasone 24mg Solution for Injection and Saline Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2020to 31 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial
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.
- Being tested
- Dexamethasone 24mg Solution for Injection, Saline Solution for Injection
- Keywords
- postoperative pain, dexamethasone, pain management
- Medical subject headings
- Hip Dislocation, Pain, Postoperative, Postoperative Nausea and Vomiting, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 24mg Solution for InjectionDrug
Also called Dexa
Administrated i.v.
Saline Solution for InjectionDrug
Also called Saline
administrated i.v.
| Study group | Role | What they receive |
|---|---|---|
| A; Dexamethasone twice | Experimental | 24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours. Receives: 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 Receives: 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 Receives: Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-48 hours postoperatively
Secondary outcomes (7)
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).
Measured: 24, 48 hours postoperatively
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
Morphine consumption in milligrams after the operation.
Measured: 48 hours - day 14 postoperatively
Postoperative nausea and vomiting
Nausea and vomiting are evaluated using a 4 point scale: none, mild, moderate, severe
Measured: 24 and 48 hours postoperatively
Antiemetic consumption
Evaluation of cumulated antiemetic consumption in mg and drug will be assessed.
Measured: 0-48 hours postoperatively
Sleep
Sleep quality will be assessed using the VAS scale (0-100)
Measured: 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.
Measured: 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.
Measured: 0-8 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start12 Nov 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Viktoria Lindberg-Larsen, Odense University Hospital
- Investigators
- Viktoria Lindberg-Larsen, MD, PhD, Study chair, Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874936
- Sponsor's protocol ID
- SO_SH_01_2019
- Other IDs
- 2019_000402_30, 2019
- Acronym
- PAODEX
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2019
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40460271
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03874936
- Acronym / sponsor ID
- PAODEX / SO_SH_01_2019
- Keywords
- postoperative pain, dexamethasone, pain management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A; Dexamethasone twice | Experimental | Drug: Dexamethasone 24mg Solution for Injection24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours. |
| B; Dexamethasone once | Experimental | Drug: Dexamethasone 24mg Solution for Injection, Drug: Saline Solution for Injection24mg 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 | Drug: Saline Solution for Injectionplacebo intravenous just before the operation and repeated after 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 24mg Solution for InjectionAlso: DexaAdministrated i.v. | Drug | A; Dexamethasone twice, B; Dexamethasone once |
| Saline Solution for InjectionAlso: Salineadministrated i.v. | Drug | B; Dexamethasone once, C; Placebo twice |
Primary outcome
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.
7 secondary outcomes
Postoperative pain intensity after 48 hours.
Time frame: 24, 48 hours postoperatively
Cumulated postoperative morphine consumption from 48 hours until day 14 post operation
Time frame: 48 hours - day 14 postoperatively
Postoperative nausea and vomiting
Time frame: 24 and 48 hours postoperatively
Antiemetic consumption
Time frame: 0-48 hours postoperatively
Sleep
Time frame: 0-7 days postoperatively
Timed up and go test
Time frame: 24, 48 hours postoperatively
Serious adverse events (SAE)
Time frame: 0-8 weeks after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 40460271Lindberg-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktoria Lindberg-Larsen, MD, PhD study chair
Dept. of Anesthesiology and Intensive Care Medicine, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone 24mg Solution for Injection and Saline Solution for Injection in people with Dexamethasone and Hip Dysplasia, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulated postoperative morphine consumption in milligrams after 48 hours. (time frame: 0-48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.