Comparison between ultrasound-guided interscalene nerve block and procedural sedation with fentanyl and propofol for reduction of anterior shoulder dislocations
Objective: To compare two methods of achieving analgesia and muscle relaxation for reduction of anterior shoulder dislocations: procedural sedation with propofol and fentanyl, and ultrasound-guided interscalene nerve block with lidocaine 2%.
Inclusion criteria: all patients with diagnosis of anterior shoulder dislocation presenting to Bahonar hospital, Kerman, Iran.
Exclusion criteria: Any contraindications to the drugs assigned for the patient in each group, or any Patient who doesn't accept to enter the study or to undergo the procedure for analgesia which was ranoimized into; diagnosis of accompanying fracture or neurovascular deficit.
Study population and sample size: All patients with a diagnosis of anterior shoulder dislocation are enrolled in the study regarding exclusion criteria. For each group(procedural sedation and nerve block), 30 patients will be recruited.
Intervention and outcomes:Reduction of shoulder dislocations is an emergency procedure and should be done immediately after the diagnosis is confirmed by physical examination and X-rays. Procedural sedation with propofol and fentanyl is one of the most common methods of achieving analgesia and relaxation for reduction of shoulder dislocations. We will perform interscalene nerve block under the guidance of ultrasound by using 30mls of lidocaine 2% and compare the outcome(s) with the propofol and fentanyl group. The primary outcome includes patients' stay time in the emergency department in minute, and secondary outcomes include pain score (by numeric rating scale method) at reduction, patient satisfaction with the procedure, and the number of attempts at reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122615941N1
Registration date:2015-01-25, 1393/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Amirhossein Mirafzal
Name of organization / entity
Kerman University of Medical sceinces
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 4638
Email address
mirafzal@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
No funding source available
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between ultrasound-guided interscalene nerve block and procedural sedation with fentanyl and propofol for reduction of anterior shoulder dislocations
Public title
Interscalene nerve block vs. systemic sedatives for reduction of shoulder dislocations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with diagnosis of anterior shoulder dislocation presenting to Bahonar hospital in Kerman
Exclusion criteria: Any contraindications to the drugs assigned for the patient in each group; Patient doesn't accept to enter the study or to undergo the procedure for analgesia which was ranoimized into; diagnosis of accompanying fracture in the shoulder joint or neurovascular deficit
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Afzalipoor paradise, Imam Boulvarde, Kerman, IRAN
City
Kerman
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
10/61/563
Health conditions studied
1
Description of health condition studied
anterior shoulder dislocation
ICD-10 code
M24.3
ICD-10 code description
Pathological dislocation and subluxation of joint, not elsewhere classified
Primary outcomes
1
Description
ED stay time
Timepoint
Discharge time
Method of measurement
Answer sheet- researcher
Secondary outcomes
1
Description
Pain score at reduction
Timepoint
Reduction time
Method of measurement
Researcher- Answer sheet
2
Description
Patient satisfaction
Timepoint
End of Reduction
Method of measurement
Researcher- Answer sheet
3
Description
Total attempts at reduction
Timepoint
End of Reduction
Method of measurement
Researcher- Answer sheet
Intervention groups
1
Description
Intervention: Ultrasound-guided interscalene nerve block with lidocaine 2% 20cc
Category
Treatment - Drugs
2
Description
Control: propofol 1mg/kg IV bolus + fentanyl 2micrograms/kg IV bolus
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Academic Hospital
Full name of responsible person
Amirhossein Mirafzal
Street address
Bagh-e Melli cross st, Shariati St, Kerman, IRAN
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Hayatbakhsh, MD
Street address
Afzaipoor paradise, Imam Khomeini Boulvarde
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?