Shoulder DislocationPhase 4NCT03625076
IAL vs PS for Anterior Shoulder Dislocations
A Phase 4 study testing Intra-articular Lidocaine and Procedural Sedation with etomidate or propofol in people with Shoulder Dislocation, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
Trial summary
This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Intra-articular Lidocaine and Procedural Sedation with etomidate or propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.
Who cannot join
- Pregnant or breastfeeding
- Is a prisoner.
- Known allergy to one of the study drugs.
- Altered mental status.
- Shoulder fracture (other than a Hill-Sachs) associated with the dislocation.
- Attending provider excludes patient.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kendall Regional Medical Center
Miami, Florida, 33175
Tony Zitek, MD, 305-480-6602, zitek10@gmail.com
About this study
Official title: Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations
This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.
Read the detailed description
This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.
- Conditions
- Shoulder Dislocation
- Being tested
- Intra-articular Lidocaine, Procedural Sedation with etomidate or propofol
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular LidocaineDrug
20 mL of 1% Lidocaine will be injected into the joint of the dislocated shoulder. Afterwards, the physician will attempt to reduce the shoulder using a technique of his or her choice.
Procedural Sedation with etomidate or propofolDrug
Procedural sedation using etomidate or propofol (physician's choice) will be performed. The dose of the drugs will also be left the treating physician. The physician will then attempt to reduce the shoulder using a technique of his or her choice.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Lidocaine | Experimental | 20 mL of 1% lidocaine injected into the joint of the dislocated shoulder Receives: Drug: Intra-articular Lidocaine |
| Procedural Sedation | Active comparator | Intravenous etomidate or propofol Receives: Drug: Procedural Sedation with etomidate or propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Length of Stay
The elapsed time over which the patient is physically in the emergency department
Measured: Anticipated 1-4 hours
Secondary outcomes (2)
Number of Reduction Attempts
The number of attempts it took the physician to reduce the shoulder dislocation
Measured: Each attempt takes under 5 minutes
Patient Satisfaction
The patient's satisfaction on a scale from 0-10
Measured: The patient is asked their satisfaction just prior to discharge (generally within 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Jun 2018
- Primary completion2 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kendall Healthcare Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625076
- Sponsor's protocol ID
- 2018-233-Non-NSU Health
- Status last verified
- Aug 2019
- First submitted
- 18 Jun 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If, after data collection, we feel that the release of IPD will increase the clarity of our data, we might make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Lidocaine vs Procedural Sedation for Anterior Shoulder Dislocations
- ClinicalTrials.gov ID
- NCT03625076
- Acronym / sponsor ID
- 2018-233-Non-NSU Health
- Conditions
- Shoulder Dislocation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kendall Healthcare Group, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 10 Aug 2018 (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.
This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.
Detailed description
This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Lidocaine | Experimental | Drug: Intra-articular Lidocaine20 mL of 1% lidocaine injected into the joint of the dislocated shoulder |
| Procedural Sedation | Active comparator | Drug: Procedural Sedation with etomidate or propofolIntravenous etomidate or propofol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Is a prisoner.
- Known allergy to one of the study drugs.
- Altered mental status.
- Shoulder fracture (other than a Hill-Sachs) associated with the dislocation.
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 |
|---|---|---|
| Intra-articular Lidocaine20 mL of 1% Lidocaine will be injected into the joint of the dislocated shoulder. Afterwards, the physician will attempt to reduce the shoulder using a technique of his or her choice. | Drug | Intra-articular Lidocaine |
| Procedural Sedation with etomidate or propofolProcedural sedation using etomidate or propofol (physician's choice) will be performed. The dose of the drugs will also be left the treating physician. The physician will then attempt to reduce the shoulder using a technique of his or her choice. | Drug | Procedural Sedation |
Primary outcome
Emergency Department Length of Stay
Time frame: Anticipated 1-4 hours
The elapsed time over which the patient is physically in the emergency department
2 secondary outcomes
Number of Reduction Attempts
Time frame: Each attempt takes under 5 minutes
Patient Satisfaction
Time frame: The patient is asked their satisfaction just prior to discharge (generally within 4 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Undecided. If, after data collection, we feel that the release of IPD will increase the clarity of our data, we might make IPD available to other researchers.
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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.
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 Intra-articular Lidocaine and Procedural Sedation with etomidate or propofol in people with Shoulder Dislocation, run by Kendall Healthcare Group, Ltd. 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 1 inclusion and 6 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 13 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Zitek, MD (305-480-6602, zitek10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Length of Stay (time frame: Anticipated 1-4 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 13 Aug 2019.