Protocol summary

Study aim
The comparative study of postoperative shoulder pain under pain anesthesia with sedation for performing the PSA procedure and supracapacular nerve block under ultrasound guide in patients referred to the emergency department
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 50.
Settings and conduct
In this research, all patients referred to the Emergency Department of Shohada-e- Haftome tir and Hazrat Rasoul Akram Hospital, who suffered from Shoulder dislocation will be enrolled. Patients will be randomly divided into two groups based on 10 blocks. A total of 100 patients will be examined. Data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Shohada-e- Haftome tir , Hazrat Rasoul Akram and Firouzgar Hospital, who suffered from Shoulder dislocation will be enrolled. Inclusion criteria: Shoulder dislocation with or without trauma, patients over 18 years old. Exclusion criteria: Patients over 70 years old, The presence of fracture along the dislocation, chronic, kidney and liver disease, systolic pressure less than 90 mmHg, heart rate less than 60 times per minute
Intervention groups
In Control group, Ketamine will be given to the patient at a dose of 1-2mg/kg as a titration to provide a suitable sedation. In Intervention group, An ultrasound device is used for the 5 -10 MHz linear probe. The linear probe is placed in parallel with the sphagnum throat, and is injected from the medial to the lateral, about 2-3 mm on the probe medial side, 22 gauge syringe, containing 5 cc of lidocaine in the scapular area.
Main outcome variables
Pain relief, Patient Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151003024317N5
Registration date: 2019-01-28, 1397/11/08
Registration timing: prospective

Last update: 2019-01-28, 1397/11/08
Update count: 0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of postoperative shoulder pain under pain anesthesia with sedation for performing the procedure and supracapacular nerve block under ultrasound guide in patients referred to the emergency department
Public title
Shoulder dislocation treatment under the anesthetic with sedation for performing the procedure and supracapacular nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder dislocation with or without trauma Patients over 18 years old
Exclusion criteria:
Patients over 70 years old The presence of fracture along the dislocation Chronic kidney and liver disease Systolic pressure less than 90 mmHg Heart rate less than 60 times per minute
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 10 blocks will be considered for sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be analyzed by person who is blind to study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.IUMS.FMD.REC.1397.127

Health conditions studied

1

Description of health condition studied
Shoulder dislocation
ICD-10 code
M24.31
ICD-10 code description
Pathological dislocation of shoulder, not elsewhere classified

Primary outcomes

1

Description
Pain relief
Timepoint
After 5, 10 and 15 minutes after using the drug
Method of measurement
From 1 to 10 (Based on Visual Analogue Scale).

2

Description
Patient Satisfaction
Timepoint
After the shoulder is laid
Method of measurement
From 1 to 5 (Based on numerical scale).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: An ultrasound device is used for the 5 -10 MHz linear probe. The linear probe is placed in parallel with the sphagnum throat, and is injected from the medial to the lateral, about 2-3 mm on the probe medial side, 22 gauge syringe, containing 5 cc of lidocaine in the scapular area.
Category
Treatment - Devices

2

Description
Control group: Ketamine will be given to the patient at a dose of 1-2mg/kg as a titration to provide a suitable sedation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasoul Akram hospital
Full name of responsible person
Reza karbor
Street address
Emergency department, Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
Email
hrmc@iums.ac.ir

2

Recruitment center
Name of recruitment center
Shohada-e- Haftome tir Hospital
Full name of responsible person
Reza karbor
Street address
hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Email
web7tir@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakooti
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza karbor
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Departement, Rasool Akram Hospital, Niayesh St. Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1344985644
Phone
+98 21 6608 0654
Email
dr_karbor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saieed Abbasi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Email
Saieedabbasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza karbor
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Departement, Rasool Akram Hospital, Niayesh St. Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1344985644
Phone
+98 21 6608 0654
Email
dr_karbor@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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