Reduction of acute anterior shoulder dislocation with or without the use of articular lidocaine anaesthesia
| ISRCTN | ISRCTN27127703 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27127703 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/04/2011
- Registration date
- 26/04/2011
- Last edited
- 27/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marcel Tamaoki
Scientific
Scientific
Rua das Rosas 126 apto 73
São Paulo
04048-000
Brazil
| Phone | +55 11 8162 1709 |
|---|---|
| marceltamaoki@terra.com.br |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Reduction of acute anterior shoulder dislocation with or without the use of articular lidocaine anaesthesia: a prospective randomised controlled trial |
| Study objectives | The intra-articular lidocaine could reduce pain for treatment of shoulder dislocation. |
| Ethics approval(s) | Hospital Sao Paulo Research Ethics Committee (Cpmitê de Ética em Pesquisa Hospital São Paulo) approved on 08/08/2008 (ref: CEP 1019/08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua das Rosas 126 apto 73
São Paulo
04048-000
Brazil
04048-000
Brazil
Sponsor information
Federal University of Sao Paulo (Universidade Federal de São Paulo) (Brazil)
University/education
University/education
Disciplina de Mão e Membro Superior
Rua Borges Lagoa 786
São Paulo
04023-900
Brazil
| tamaoki@unifesp.br | |
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
Hospital/treatment centre
Hospital Sao Paulo (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2012 | Yes | No |
