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RecruitingNCT06531590Updated Aug 1, 2024

Anterior Shoulder Dislocation at Emergency Department

An observational study in Shoulder Dislocation, Analgesia and Pain, Shoulder, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Saglik Bilimleri Universitesi · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study 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, 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:

  1. ketamine group
  2. interscalene nerve block group
  3. suprascapular nerve block group
  4. 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
02

Conditions studied

  • Shoulder Dislocation
  • Analgesia
  • Pain, Shoulder

Keywords

  • shoulder dislocation
  • interscalene nerve block
  • suprascapular nerve block
  • intraarticular lidocaine injection
  • emergency department
03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 140 is above the median of 86 across 28 observational studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

patients followed at emergency department after shoulder dislocation who received analgesic treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients aged 18 years and older

Exclusion criteria

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Etlik City Hospital
    Ankara, Yenimahalle 06110, Turkey
    Recruiting
    • gulsen akcay, ass. prof. · Contactgulakcay@yahoo.com.tr · +905052874949
    • serife busra uysal, resident · Contactserifebusrauysal@gmail.com · +905321131688
    • serife busra uysal, resident · Sub investigator
    • gulsen akcay, ass.prof. · Principal investigator
    • bedriye muge sonmez, ass. prof · Sub investigator
    • huseyin bilgehan cevik, ass.prof. · Sub investigator
    • ilker sirin, specialist · Sub investigator
08

References and documents

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 35667730 ↗
  • 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. PubMed 35872652 ↗
  • 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. PubMed 37741738 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06531590
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Aug 1, 2024

Study contacts

gulsen akcay, ass. prof.
Contact
gulakcay@yahoo.com.tr
+905052874949
serife busra uysal, resident
Contact
serifebusrauysal@gmail.com
+905321131688
gulsen akcay, ass. prof.
study director · ass. prof. of organization

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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