Pain, PostoperativePhase 4DEXRARNCT02884180
DEXRAR: DEXamethasone in Revision ARthroplasty
A Phase 4 study testing Dexamethasone and Saline isotonic in people with Pain, Postoperative, run by Daniel Hägi-Pedersen at 1 site in Denmark.
Trial summary
Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial Trial acronym: DEXRAR Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexamethasone and Saline isotonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- 31 May 2017to 31 Mar 2025
- Phase
- Phase 4
- 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
- Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
- Age > 18
- American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.
- Body mass index (BMI) > 18 and < 45
- Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test
- Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
Who cannot join
- Patients who cannot cooperate with the trial.
- Concomitant participation in another trial involving medication
- Patients who cannot understand or speak Danish.
- Patients with allergy to medicines used in the trial.
- Patients with daily use of methadone.
- Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
- Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial
Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial
Trial acronym: DEXRAR
Read more
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy.
Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia
Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v.
Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients.
Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.
- Conditions
- Pain, Postoperative
- Being tested
- Dexamethasone, Saline isotonic
- Keywords
- Dexamethasone, Arthroplasty, Replacement, Knee, Revision
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
A dose of 24 mg dexamethasone given after start of anaesthesia
Saline isotonicDrug
A dose of 6 ml of isotonic saline given after start of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Dexamethasone 24 mg i.v. after start of anaesthesia Receives: Drug: Dexamethasone |
| Treatment B | Placebo comparator | Saline isotonic i.v. after start of anaesthesia Receives: Drug: Saline isotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption the first 24 hours postoperatively
Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively
Measured: 0-24 hours postoperatively
Secondary outcomes (14)
Pain during movement at 6 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 6 hours postoperatively
Pain during movement at 24 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 24 hours postoperatively
Pain at rest at 6 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 6 hours postoperatively
Pain at rest at 24 hours postoperatively (visual analogue scale)
Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100
Measured: 24 hours postoperatively
Timed up and go test
Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again
Measured: 24 hours postoperatively
Adverse events
Number of patients with one or more adverse events in the intervention period (0-24 hours)
Measured: 0 - 24 hours postoperatively
Nausea at 6 hours postoperatively (Verbal rating scale)
Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 6 hours postoperatively
Nausea at 24 hours postoperatively (Verbal rating scale)
Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 24 hours postoperatively
Vomiting the first 24 hours postoperatively
Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively
Measured: 0-24 hours postoperatively
Dizziness at 6 hours postoperatively (Verbal rating scale)
Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 6 hours postoperatively
Dizziness at 24 hours postoperatively (Verbal rating scale)
Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 24 hours postoperatively
Sedation at 6 hours postoperatively (Verbal rating scale)
Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 6 hours postoperatively
Sedation at 24 hours postoperatively (Verbal rating scale)
Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Measured: 24 hours postoperatively
Anti-emetic treatment the first 24 hours postoperatively
Consumption of ondansetron in the period 0-24 hours postoperatively
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start31 May 2017
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Why it stopped: The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Hägi-Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Hägi-Pedersen, Naestved Hospital
- Investigators
- Daniel Hägi-Pedersen, MD, Study chair, Department of Anaesthesiology, Næstved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884180
- Sponsor's protocol ID
- SM1-DHAG-2016
- Other IDs
- 2016-002769-72, 2016
- Acronym
- DEXRAR
- Status last verified
- May 2025
- First submitted
- 25 Aug 2016
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial
- ClinicalTrials.gov ID
- NCT02884180
- Acronym / sponsor ID
- DEXRAR / SM1-DHAG-2016
- Conditions
- Pain, Postoperative
- Keywords
- Dexamethasone, Arthroplasty, Replacement, Knee, Revision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Daniel Hägi-PedersenUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial
Trial acronym: DEXRAR
Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy.
Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia
Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v.
Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients.
Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: DexamethasoneDexamethasone 24 mg i.v. after start of anaesthesia |
| Treatment B | Placebo comparator | Drug: Saline isotonicSaline isotonic i.v. after start of anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
- Age > 18
- American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.
- Body mass index (BMI) > 18 and < 45
- Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test
Key exclusion criteria (7 listed)
- Patients who cannot cooperate with the trial.
- Concomitant participation in another trial involving medication
- Patients who cannot understand or speak Danish.
- Patients with allergy to medicines used in the trial.
- Patients with daily use of methadone.
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 |
|---|---|---|
| DexamethasoneA dose of 24 mg dexamethasone given after start of anaesthesia | Drug | Treatment A |
| Saline isotonicA dose of 6 ml of isotonic saline given after start of anaesthesia | Drug | Treatment B |
Primary outcome
Morphine consumption the first 24 hours postoperatively
Time frame: 0-24 hours postoperatively
Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively
14 secondary outcomes
Pain during movement at 6 hours postoperatively (visual analogue scale)
Time frame: 6 hours postoperatively
Pain during movement at 24 hours postoperatively (visual analogue scale)
Time frame: 24 hours postoperatively
Pain at rest at 6 hours postoperatively (visual analogue scale)
Time frame: 6 hours postoperatively
Pain at rest at 24 hours postoperatively (visual analogue scale)
Time frame: 24 hours postoperatively
Timed up and go test
Time frame: 24 hours postoperatively
Adverse events
Time frame: 0 - 24 hours postoperatively
Nausea at 6 hours postoperatively (Verbal rating scale)
Time frame: 6 hours postoperatively
Nausea at 24 hours postoperatively (Verbal rating scale)
Time frame: 24 hours postoperatively
Vomiting the first 24 hours postoperatively
Time frame: 0-24 hours postoperatively
Dizziness at 6 hours postoperatively (Verbal rating scale)
Time frame: 6 hours postoperatively
Dizziness at 24 hours postoperatively (Verbal rating scale)
Time frame: 24 hours postoperatively
Sedation at 6 hours postoperatively (Verbal rating scale)
Time frame: 6 hours postoperatively
Sedation at 24 hours postoperatively (Verbal rating scale)
Time frame: 24 hours postoperatively
Anti-emetic treatment the first 24 hours postoperatively
Time frame: 0-24 hours postoperatively
Results and safety
The study was stopped early (reason given: The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- 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.
Daniel Hägi-Pedersen, MD study chair
Department of Anaesthesiology, Næstved Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Saline isotonic in people with Pain, Postoperative, run by Daniel Hägi-Pedersen 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 May 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: The study had met its original objectives for the primary endpoint. A transition to a new regulatory system would have introduced additional costs and delays. Therefore, a strategic decision was made to stop before final enrollment.). Results are not available in the source record.
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?
Morphine consumption the first 24 hours postoperatively (time frame: 0-24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.