Shoulder Impingement SyndromePhase 4NCT01414569
Dexamethasone for Pain After Shoulder Surgery
A Phase 4 study testing Dexamethasone in people with Shoulder Impingement Syndrome and Arthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shoulder Impingement Syndrome, Arthritis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Jun 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthroscopic subacromial decompression and/or acromioclavicular resection
- General anaesthesia
- Daysurgery, Horsens Hospital
Who cannot join
- Incompetent
- Pregnant
- Age under 18 or over 90 years
- Allergy toward dexamethasone
- Diabetes
- Active gastric ulcer
Show all 12Show fewer
- Untreated hypertension
- Glaucoma
- Daily use of glucocorticoids or strong opioids
- Daily use of analgesics for unrelated illness
- Myasthenia gravis
- Mitochondrial disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.
- Conditions
- Shoulder Impingement Syndrome, Arthritis
- Being tested
- Dexamethasone
- Medical subject headings
- Shoulder Impingement Syndrome, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Fortecortin
Singe dose preoperatively in 100 ml saline intravenously
| Study group | Role | What they receive |
|---|---|---|
| 8 mg dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
| Placebo, saline | Placebo comparator | Not described Receives: Drug: Dexamethasone |
| 40 mg dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score by numeric rating scale
Measured: At 8 hours postoperatively
Secondary outcomes (2)
Use of analgesics
Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.
Measured: During hospital stay, about 4 hours
Pain score by numeric rating scale
On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.
Measured: At about 8 a.m. on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2013
- Study completionJun 2013
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 Shoulder Impingement SyndromeStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital, Central Denmark Region, The Hede Nielsen Family Foundation, The Danish Rheumatism Association
- Responsible party
- Sponsor
- Investigators
- Karen T Bjørnholdt, MD, Principal investigator, Aarhus University, Horsens HospitalKjeld Søballe, Prof. dr.med., Study chair, Aarhus University HospitalLone Nikolajsen, ph.d., MD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414569
- Sponsor's protocol ID
- KTB-002
- Other IDs
- 2011-003082-15
- Status last verified
- Jun 2013
- First submitted
- 9 Aug 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.
PubMed 24825530
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT01414569
- Acronym / sponsor ID
- KTB-002
- Conditions
- Shoulder Impingement Syndrome, Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Horsens Hospital, Central Denmark Region, The Hede Nielsen Family Foundation, The Danish Rheumatism Association
- Study start
- Nov 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Aug 2011 (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.
The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.
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 |
|---|---|---|
| 8 mg dexamethasone | Active comparator | Drug: Dexamethasone |
| Placebo, saline | Placebo comparator | Drug: Dexamethasone |
| 40 mg dexamethasone | Experimental | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Arthroscopic subacromial decompression and/or acromioclavicular resection
- General anaesthesia
- Daysurgery, Horsens Hospital
Key exclusion criteria (12 listed)
- Incompetent
- Pregnant
- Age under 18 or over 90 years
- Allergy toward dexamethasone
- Diabetes
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 |
|---|---|---|
| DexamethasoneAlso: FortecortinSinge dose preoperatively in 100 ml saline intravenously | Drug | 40 mg dexamethasone, 8 mg dexamethasone, Placebo, saline |
Primary outcome
Pain score by numeric rating scale
Time frame: At 8 hours postoperatively
2 secondary outcomes
Use of analgesics
Time frame: During hospital stay, about 4 hours
Pain score by numeric rating scale
Time frame: At about 8 a.m. on the first postoperative day
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 4 Jun 2013.
- Derived from this study: PubMed 24825530Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.
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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.
Karen T Bjørnholdt, MD principal investigator
Aarhus University, Horsens Hospital
Kjeld Søballe, Prof. dr.med. study chair
Aarhus University Hospital
Lone Nikolajsen, ph.d., MD study chair
Aarhus 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 4 study testing Dexamethasone in people with Shoulder Impingement Syndrome and Arthritis, run by University of Aarhus 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 3 inclusion and 12 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 4 Jun 2013. 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 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?
Pain score by numeric rating scale (time frame: At 8 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 NCT01414569, 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 4 Jun 2013.