Analgesia DurationPhase 4NCT01756586
Dexamethasone and Lower Extremity Block Duration
A Phase 4 study testing Dexamethasone and Bupivacaine in people with Analgesia Duration, run by University of Chicago at 1 site in United States.
Trial summary
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia Duration
- What is being tested?
- Dexamethasone and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- foot surgery
- no contraindication to regional anesthesia
Who cannot join
- opioid dependent
- chronic pain condition
- peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.
- Conditions
- Analgesia Duration
- Being tested
- Dexamethasone, Bupivacaine
- Keywords
- popliteal block, analgesia duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
BupivacaineDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Plain bupivacaine Receives: Drug: Bupivacaine |
| Experimental | Experimental | Bupivacaine with Dexamethasone Receives: Drug: Dexamethasone; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the Duration of Block
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: no logistical support to carry out the study fairly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Analgesia DurationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756586
- Sponsor's protocol ID
- IRB12-2198
- Status last verified
- May 2017
- First submitted
- 20 Dec 2012
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone and Lower Extremity Block Duration
- ClinicalTrials.gov ID
- NCT01756586
- Acronym / sponsor ID
- IRB12-2198
- Conditions
- Analgesia Duration
- Keywords
- popliteal block, analgesia duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no logistical support to carry out the study fairly
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Dec 2012 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.
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 |
|---|---|---|
| Control | Active comparator | Drug: BupivacainePlain bupivacaine |
| Experimental | Experimental | Drug: Dexamethasone, Drug: BupivacaineBupivacaine with Dexamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75
- foot surgery
- no contraindication to regional anesthesia
Key exclusion criteria (3 listed)
- opioid dependent
- chronic pain condition
- peripheral neuropathy
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 | Drug | Experimental |
| BupivacaineControl | Drug | Control, Experimental |
Primary outcome
Increase in the Duration of Block
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Bupivacaine in people with Analgesia Duration, run by University of Chicago at 1 site in United States.
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 3 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 27 Jun 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Increase in the Duration of Block (time frame: 3 days). 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 27 Jun 2017.