Interscalene BlockPhase 4NCT02178449
Prolongation of Pain Free Time by the Use of Dexamethasone in Peripheral Nerve Blockade
A Phase 4 study testing Dexamethasone acetate and Ropivacaine in people with Interscalene Block and Shoulder Arthroscopy, run by Landesklinikum Sankt Polten at 2 sites in Austria.
Trial summary
The main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interscalene Block, Shoulder Arthroscopy, Dexamethasone
- What is being tested?
- Dexamethasone acetate and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 2 sitesAustria
- Study dates
- Mar 2014to May 2015
- 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
- atroscopy of the shoulder
- repair of the RM
Who cannot join
- patient under 18 years
- patient is fertile
- chronic opiat use more than 30mg oxycodone per day
- operations at the shoulder that involves the bone
- usage of cortisone for more than 2 weeks
- risk greater as asa III
- damage to nerves
- neuropathy at the target arm
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Landesklinikum Sankt Pölten
Sankt Pölten, Lower Austria, 3100
Christoph Hörmann, MD, +43 2742 9004, office@stpoelten.lknoe.at
Christoph Hörmann, MD
- Recruiting
Landesklinikum Sankt Pölten
Sankt Pölten, Lower Austria, 3100
Christoph Hörmann, MD, +43 2742 9004, office@stpoelten.lknoe.at
Christoph Hörmann
About this study
Official title: The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient
The main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. The current literature uses often very high volumes of ropivacain when used together with dexamethasone. The investigators try to research the effect of using dexamethsone together with low volume, high concentration ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone has an positive effect on the pain free after used together with ropivacaine at the scalene block.
- Being tested
- Dexamethasone acetate, Placebo, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone acetateDrug
PlaceboDrug
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Dexamethasone and Ropivacaine Receives: Drug: Dexamethasone acetate; Drug: Ropivacaine |
| Placebo | Active comparator | Ropivacaine and Saline Receives: Drug: Placebo; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain free time measured by the duration between block and the point at which the patient is asking for painkillers
Measured: Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.
Secondary outcomes (1)
Visual Rating Scale for Pain at Movement and Rest
Measured: Measured 10 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene BlockStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landesklinikum Sankt Polten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Hörmann, MD, Study director, Landesklinikum Sankt Polten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178449
- Sponsor's protocol ID
- DEXATrial1
- Other IDs
- GS4-EK-2/304-2013
- Status last verified
- Jun 2014
- First submitted
- 26 May 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient
- ClinicalTrials.gov ID
- NCT02178449
- Acronym / sponsor ID
- DEXATrial1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Landesklinikum Sankt PoltenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 30 Jun 2014 (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 main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. The current literature uses often very high volumes of ropivacain when used together with dexamethasone. The investigators try to research the effect of using dexamethsone together with low volume, high concentration ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone has an positive effect on the pain free after used together with ropivacaine at the scalene block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Dexamethasone acetate, Drug: RopivacaineDexamethasone and Ropivacaine |
| Placebo | Active comparator | Drug: Placebo, Drug: RopivacaineRopivacaine and Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- atroscopy of the shoulder
- repair of the RM
Key exclusion criteria (8 listed)
- patient under 18 years
- patient is fertile
- chronic opiat use more than 30mg oxycodone per day
- operations at the shoulder that involves the bone
- usage of cortisone for more than 2 weeks
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 acetate | Drug | Verum |
| Placebo | Drug | Placebo |
| Ropivacaine | Drug | Placebo, Verum |
Primary outcome
Pain free time measured by the duration between block and the point at which the patient is asking for painkillers
Time frame: Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.
1 secondary outcome
Visual Rating Scale for Pain at Movement and Rest
Time frame: Measured 10 hours after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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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.
Christoph Hörmann, MD study director
Landesklinikum Sankt Polten
2 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 acetate and Ropivacaine in people with Interscalene Block and Shoulder Arthroscopy, run by Landesklinikum Sankt Polten at 2 sites in Austria.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Hörmann, MD (+ 43 2742 9004, office@stpoelten.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain free time measured by the duration between block and the point at which the patient is asking for painkillers (time frame: Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.). 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 30 Jun 2014.