Postoperative PainPhase 4NCT05008367
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone and Isotonic saline in people with Postoperative Pain, run by Naestved Hospital at 5 sites in Denmark.
Trial summary
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 485 participants
- Where
- 5 sitesDenmark
- Study dates
- 14 Sep 2018to 7 Jun 2020
- 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
- Participation in the DEX-2-TKA-trial
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Gildhøj Privathospital
Brøndby, 2605
Bispebjerg Hospital
Copenhagen, 2400
Sjællands Universitetshospital, Køge
Køge, 4600
Næstsved Sygehus
Næstved, 4700
Odense Universitetshospital
Odense, 5000
About this study
Official title: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Read the detailed description
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Isotonic saline
- 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
24 mg intravenous Dexamethasone (6 ml)
Isotonic salineDrug
6 ml of isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | 24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day Receives: Drug: Dexamethasone |
| Treatment B | Active comparator | 24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day Receives: Drug: Dexamethasone; Drug: Isotonic saline |
| Placebo | Placebo comparator | Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative usage of morphine 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
Measured: Time Frame: 0-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start14 Sep 2018
- Primary completion11 Mar 2020
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008367
- Sponsor's protocol ID
- SM1-KAKG-2021
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05008367
- Acronym / sponsor ID
- SM1-KAKG-2021
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 17 Aug 2021 (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.
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Detailed description
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Dexamethasone24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day |
| Treatment B | Active comparator | Drug: Dexamethasone, Drug: Isotonic saline24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
| Placebo | Placebo comparator | Drug: Isotonic salinePlacebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in the DEX-2-TKA-trial
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dexamethasone24 mg intravenous Dexamethasone (6 ml) | Drug | Treatment A, Treatment B |
| Isotonic saline6 ml of isotonic saline | Drug | Placebo, Treatment B |
Primary outcome
Cumulative usage of morphine 0-48 hours postoperatively
Time frame: Time Frame: 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg
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 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 Isotonic saline in people with Postoperative Pain, run by Naestved Hospital at 5 sites 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 1 inclusion and 0 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
Cumulative usage of morphine 0-48 hours postoperatively (time frame: 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?
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 13 Sep 2021.