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 patients 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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23338733
Publication citations
-
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.