NCT06531590

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 17, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

shoulder dislocationinterscalene nerve blocksuprascapular nerve blockintraarticular lidocaine injectionemergency department

Outcome Measures

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)

    24 hours

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients aged 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35667730BACKGROUND
  • 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.

    PMID: 35872652BACKGROUND
  • 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.

    PMID: 37741738BACKGROUND

MeSH Terms

Conditions

Shoulder DislocationAgnosiaShoulder PainEmergencies

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaPainDisease AttributesPathologic Processes

Study Officials

  • gulsen akcay, ass. prof.

    ass. prof. of organization

    STUDY DIRECTOR

Central Study Contacts

gulsen akcay, ass. prof.

CONTACT

serife busra uysal, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

August 1, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations