Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/04/2011
Date assigned
26/04/2011
Last edited
27/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcel Tamaoki

ORCID ID

Contact details

Rua das Rosas 126 apto 73
São Paulo
04048-000
Brazil
+55 11 8162 1709
marceltamaoki@terra.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Reduction of acute anterior shoulder dislocation with or without the use of articular lidocaine anaesthesia: a prospective randomised controlled trial

Acronym

Study hypothesis

The intra-articular lidocaine could reduce pain for treatment of shoulder dislocation.

Ethics approval

Hospital Sao Paulo Research Ethics Committee (Cpmitê de Ética em Pesquisa Hospital São Paulo) approved on 08/08/2008 (ref: CEP 1019/08)

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anterior shoulder dislocation

Intervention

After fulfilling the study inclusion and exclusion criteria, each patient received a sequential registration number and a sealed, opaque envelope marked with the number corresponding to their registration. The envelope contained information regarding the treatment method that was randomly assigned to the patient’s registration number. The attending physician led the patient to a waiting room where after the door was closed and the envelope was opened, either intra-articular lidocaine injection was applied or no treatment was given in accordance to the method disclosed. In both cases, the anatomical region of the arm corresponding to the application of intra-articular anaesthetic was covered with dressings to mask whether or not the intervention had been performed. Whether or not the patients underwent the intervention, all patients were placed supine on a stretcher with the affected shoulder at 60° abduction. The pull maneuver and counter-traction were performed with a bedsheet placed under their armpit.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lidocaine

Primary outcome measures

Pain was assessed through the application of a visual analogue scale at the time of pre reduction, and 1 and 5 minutes after the reduction maneuver was performed

Secondary outcome measures

1. The time span to achieve shoulder joint reduction in minutes
2. Neurological, vascular and infectious complications
3. Occurrence of failures were also assessed (defined as unsuccessful reduction after a 10-minute attempt). After 5 minutes, two other physicians were called to perform the reduction maneuver. Both were blinded to which treatment the patient had received.

Overall trial start date

01/09/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with acute anterior shoulder dislocation who were treated at the Emergency Room of Hospital Sao Paulo were included in the study.
The diagnostic criteria used were clinical findings:
1. Shoulder deformity
2. Acute pain and disability for active and passive mobility of the shoulder
3. Radiographic findings showing total loss of articular congruity between the humeral head and glenoid cavity, as evidenced by frontal, profile and axillary shoulder radiographs

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients who were diagnosed with fracture-dislocation of the shoulder joint, except those with Hill-Sachs lesions, were disqualified
2. Patients with immature skeletons (open physis), who underwent surgery, or had previous fractures in the affected shoulder
3. Patients in whom the use of lidocaine is contraindicated
4. Those who refused to sign the consent form

Recruitment start date

01/09/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua das Rosas 126 apto 73
São Paulo
04048-000
Brazil

Sponsor information

Organisation

Federal University of Sao Paulo (Universidade Federal de São Paulo) (Brazil)

Sponsor details

Disciplina de Mão e Membro Superior
Rua Borges Lagoa 786
São Paulo
04023-900
Brazil
tamaoki@unifesp.br

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Sao Paulo (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23338733

Publication citations

  1. Results

    Tamaoki MJ, Faloppa F, Wajnsztejn A, Archetti Netto N, Matsumoto MH, Belloti JC, Effectiveness of intra-articular lidocaine injection for reduction of anterior shoulder dislocation: randomized clinical trial., Sao Paulo Med J, 2012, 130, 6, 367-372.

Additional files

Editorial Notes