Shoulder DislocationNCT06531590
Anterior Shoulder Dislocation at Emergency Department
An observational study of Shoulder Dislocation and Analgesia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigator will analyze the demographic characteristics of patients presenting to emergency department with Anterior Shoulder Dislocation. Investigators will document the mechanism of injury, orthopedic classification of shoulder dislocation, associated treatments, pre-procedural pain scoring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation, Analgesia, Pain, Shoulder
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult, Older adult
Study population: patients followed at emergency department after shoulder dislocation who received analgesic treatment
Who may be able to join
- Patients aged 18 years and older
Who cannot join
- Patients who are not conscious at the time of admission and do not consent to participate in the study.
- Patients who do not have follow-up in our healthcare system or cannot be followed up.
- Patients with allergies to opioids or local anesthetics. Patients presenting to the emergency department with suspicion of multiple fractures and dislocations involving ≥2 different types of injuries will also be excluded from the study.
- Forensic cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06110
gulsen akcay, ass. prof., +905052874949, gulakcay@yahoo.com.tr
serife busra uysal, resident, +905321131688, serifebusrauysal@gmail.com
About this study
Official title: Emergency Department Management of Anterior Shoulder Dislocation Patients
In this study, investigator will analyze the demographic characteristics of patients presenting to emergency department with Anterior Shoulder Dislocation. Investigators will document the mechanism of injury, orthopedic classification of shoulder dislocation, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, as well as the duration of emergency department stay related to the preferred treatment, orthopedic consultation, and patient outcomes (discharge, admission to ward or intensive care unit, mortality). Aim of the study to investigate whether the current treatments used provide any superiority in emergency department outcomes for patients
Read the detailed description
Intravenous analgesia (Paracetamol, NSAIDs, opioids) is preferred for patients during the treatment and reduction stages of anterior shoulder dislocation. Additionally, patients may receive regional anesthesia and analgesia (lidocaine, bupivacaine). The route and dosage of analgesic administration are chosen by the attending physician managing the patient. In this study, investigators plan to observationally evaluate the analgesic management of patients without intervening in the method and dosage chosen by the primary treating physician.
Patients receiving analgesia will be chosen according to preffered treatment at emergency department. The study population will consist of patients presenting to the emergency department with shoulder dislocation who receive analgesia and fall into the following 4 treatment groups.
These 4 group will consist in:
- ketamine group
- interscalene nerve block group
- suprascapular nerve block group
- intraarticular lidocaine injection group. The study will compare these 4 treatment methods in terms of analgesia management, reduction time, comfort, and length of hospital stay for patients presenting to the emergency department with shoulder dislocation and receiving analgesia. The researcher will not interfere with the treatment decision made by the responsible physician or the treatment process
- Conditions
- Shoulder Dislocation, Analgesia, Pain, Shoulder
- Keywords
- shoulder dislocation, interscalene nerve block, suprascapular nerve block, intraarticular lidocaine injection, emergency department
- Medical subject headings
- Shoulder Dislocation, Agnosia, Shoulder Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ketamine group | patients receiving ketamine as analgesic after shoulder dislocation | |
| intraarticular lidocaine injection group | patients receiving intraarticular lidocaine injection as analgesic after shoulder dislocation | |
| interscalene nerve block group | patients receiving interscalene nerve block group as analgesic after shoulder dislocation | |
| suprascapular nerve block group | patients receiving suprascapular nerve block group as analgesic after shoulder dislocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder reduction
succesful reduction of shoulder joint and assessment of pain before and after analgesic treatments with pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531590
- Sponsor's protocol ID
- anterior shoulder dislocation
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buren MA, Theologis A, Zuraek A, Behrends M, Clark AJ, Leung JM. Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial. BMJ Open. 2022 Jun 6;12(6):e059416. doi: 10.1136/bmjopen-2021-059416.
PubMed 35667730Hayashi M, Kano K, Kuroda N, Yamamoto N, Shiroshita A, Kataoka Y. Comparative efficacy of sedation or analgesia methods for reduction of anterior shoulder dislocation: A systematic review and network meta-analysis. Acad Emerg Med. 2022 Oct;29(10):1160-1171. doi: 10.1111/acem.14568. Epub 2022 Aug 11.
PubMed 35872652Gawel RJ, Grill R, Bradley N, Luong J, Au AK. Ultrasound-Guided Peripheral Nerve Blocks for Shoulder Dislocation in the Emergency Department: A Systemic Review. J Emerg Med. 2023 Nov;65(5):e403-e413. doi: 10.1016/j.jemermed.2023.05.021. Epub 2023 Jun 9.
PubMed 37741738
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Management of Anterior Shoulder Dislocation Patients
- ClinicalTrials.gov ID
- NCT06531590
- Acronym / sponsor ID
- anterior shoulder dislocation
- Conditions
- Shoulder Dislocation, Analgesia, Pain, Shoulder
- Keywords
- shoulder dislocation, interscalene nerve block, suprascapular nerve block, intraarticular lidocaine injection, emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Aug 2024 (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.
In this study, investigator will analyze the demographic characteristics of patients presenting to emergency department with Anterior Shoulder Dislocation. Investigators will document the mechanism of injury, orthopedic classification of shoulder dislocation, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, as well as the duration of emergency department stay related to the preferred treatment, orthopedic consultation, and patient outcomes (discharge, admission to ward or intensive care unit, mortality). Aim of the study to investigate whether the current treatments used provide any superiority in emergency department outcomes for patients
Detailed description
Intravenous analgesia (Paracetamol, NSAIDs, opioids) is preferred for patients during the treatment and reduction stages of anterior shoulder dislocation. Additionally, patients may receive regional anesthesia and analgesia (lidocaine, bupivacaine). The route and dosage of analgesic administration are chosen by the attending physician managing the patient. In this study, investigators plan to observationally evaluate the analgesic management of patients without intervening in the method and dosage chosen by the primary treating physician.
Patients receiving analgesia will be chosen according to preffered treatment at emergency department. The study population will consist of patients presenting to the emergency department with shoulder dislocation who receive analgesia and fall into the following 4 treatment groups.
These 4 group will consist in:
- ketamine group
- interscalene nerve block group
- suprascapular nerve block group
- intraarticular lidocaine injection group. The study will compare these 4 treatment methods in terms of analgesia management, reduction time, comfort, and length of hospital stay for patients presenting to the emergency department with shoulder dislocation and receiving analgesia. The researcher will not interfere with the treatment decision made by the responsible physician or the treatment process
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ketamine group | – | –patients receiving ketamine as analgesic after shoulder dislocation |
| intraarticular lidocaine injection group | – | –patients receiving intraarticular lidocaine injection as analgesic after shoulder dislocation |
| interscalene nerve block group | – | –patients receiving interscalene nerve block group as analgesic after shoulder dislocation |
| suprascapular nerve block group | – | –patients receiving suprascapular nerve block group as analgesic after shoulder dislocation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients followed at emergency department after shoulder dislocation who received analgesic treatment
Key inclusion criteria (1 listed)
- Patients aged 18 years and older
Key exclusion criteria (4 listed)
- Patients who are not conscious at the time of admission and do not consent to participate in the study.
- Patients who do not have follow-up in our healthcare system or cannot be followed up.
- Patients with allergies to opioids or local anesthetics. Patients presenting to the emergency department with suspicion of multiple fractures and dislocations involving ≥2 different types of injuries will also be excluded from the study.
- Forensic cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
shoulder reduction
Time frame: 24 hours
succesful reduction of shoulder joint and assessment of pain before and after analgesic treatments with pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 35667730Buren MA, Theologis A, Zuraek A, Behrends M, Clark AJ, Leung JM. Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial. BMJ Open. 2022 Jun 6;12(6):e059416. doi: 10.1136/bmjopen-2021-059416.
- Background: PubMed 35872652Hayashi M, Kano K, Kuroda N, Yamamoto N, Shiroshita A, Kataoka Y. Comparative efficacy of sedation or analgesia methods for reduction of anterior shoulder dislocation: A systematic review and network meta-analysis. Acad Emerg Med. 2022 Oct;29(10):1160-1171. doi: 10.1111/acem.14568. Epub 2022 Aug 11.
- Background: PubMed 37741738Gawel RJ, Grill R, Bradley N, Luong J, Au AK. Ultrasound-Guided Peripheral Nerve Blocks for Shoulder Dislocation in the Emergency Department: A Systemic Review. J Emerg Med. 2023 Nov;65(5):e403-e413. doi: 10.1016/j.jemermed.2023.05.021. Epub 2023 Jun 9.
- Individual participant dataSharing planned: No
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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.
gulsen akcay, ass. prof. study director
ass. prof. of organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dislocation and Analgesia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 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 1 Aug 2024. 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 Turkey (Türkiye). 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.
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 gulsen akcay, ass. prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder reduction (time frame: 24 hours). 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 NCT06531590, which also lists 3 linked publications.
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 1 Aug 2024.