- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531590
Anterior Shoulder Dislocation at Emergency Department
Emergency Department Management of Anterior Shoulder Dislocation Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gulsen AKCAY, Ass. Prof.
- Phone Number: +905052874949
- Email: gulakcay@yahoo.com.tr
Study Contact Backup
- Name: serife busra uysal, resident
- Phone Number: +905321131688
- Email: serifebusrauysal@gmail.com
Study Locations
-
-
Yenimahalle
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Ankara, Yenimahalle, Turkey, 06110
- Recruiting
- Etlik City Hospital
-
Contact:
- Gulsen AKCAY, Ass. Prof.
- Phone Number: +905052874949
- Email: gulakcay@yahoo.com.tr
-
Sub-Investigator:
- ilker sirin, specialist
-
Principal Investigator:
- gulsen akcay, ass.prof.
-
Contact:
- serife busra uysal, resident
- Phone Number: +905321131688
- Email: serifebusrauysal@gmail.com
-
Sub-Investigator:
- serife busra uysal, resident
-
Sub-Investigator:
- bedriye muge sonmez, ass. prof
-
Sub-Investigator:
- huseyin bilgehan cevik, ass.prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 18 years and older
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: gulsen akcay, ass. prof., ass. prof. of organization
Publications and helpful links
General 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.
- Hayashi 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.
- Gawel 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- anterior shoulder dislocation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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