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A comparative study of interscalene block and supra scapular block with axillary nerve block, under ultrasound guidance to relieve pain after arthroscopic surgery of shoulder

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History
# Registration date Revision Id
2 2020-03-23, 1399/01/04 132370
1 2018-11-12, 1397/08/21 66692
Changes made to previous revision

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  • General information

    2017-10-07, 1396/07/15
    2018-11-07, 1397/08/16
    2018-06-05, 1397/03/15
    2019-07-05, 1398/04/14
    2017-10-27, 1396/08/05
    2018-11-25, 1397/09/04
    2018-07-13, 1397/04/22
    2019-08-10, 1398/05/19
    2018-10-02, 1397/07/10
    2019-09-10, 1398/06/19
    empty
    We have reset the recruitment dates.
    empty
    تغییر دادن تاریخ نمونه گیری

  • Health conditions studied

    #1
    pain in loint
    pain in joint

  • Recruitment centers

    #1
    Name of recruitment center - English: Rasool Akram Hospital
    Name of recruitment center - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Poupak Rahim Zadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Street address - English: Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh “St.”,Sattarkahn “Ave.”, Tehran, Iran
    Street address - Persian: تهران، خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم ،طبقه 4، اتاق عمل درد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6651 5001
    Fax:
    Email: P-Rahimzadeh@tums.ac.ir
    Web page address:
    Name of recruitment center - English: Rasool Akram Hospital
    Name of recruitment center - Persian: بیمارستان رسول اکرم
    Full name of responsible person - English: Poupak Rahim Zadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Street address - English: Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh St.,Sattarkahn Ave., Tehran, Iran
    Street address - Persian: تهران، خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم ،طبقه 4، اتاق عمل درد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6651 5001
    Fax:
    Email: P-Rahimzadeh@tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice-Chancellor of research, IRAN University of Medical Sciences
    Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Street address - English: Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8163 3685
    Fax:
    Email: PR@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Kazem Malakuti
    Full name of responsible person - Persian: سید کاظم ملکوتی
    Street address - English: Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
    Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 8163 3685
    Fax:
    Email: PR@iums.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: p-rahimzadeh@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: rahimzadeh.p@iums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: p-rahimzadeh@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: rahimzadeh.p@iums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: p-rahimzadeh@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Poupak Rahimzadeh
    Full name of responsible person - Persian: پوپک رحیم زاده
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
    Street address - Persian: بزرگراه شهید همت غرب، ساختمان مرکزی. طبقه 5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1916737183
    Phone: +98 21 8670 2503
    Mobile: +98 912 106 4483
    Fax: +98 21 6650 9059
    Email: rahimzadeh.p@iums.ac.ir
    Web page address:

Protocol summary

Study aim
The aim of current study is to compare interscalene nerve block with suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after arthroscopic sholder surgery
Design
Clinical trial study, with two parallel groups, double blinded, randomized
Settings and conduct
Sixty patients with arthroscopic shoulder surgery were randomly divided into two equal groups and will undergo interscalene nerve block or suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-60 years old Patients with ASA I,II Exclusion criteria: Allergy to local anesthesia Patients with liver disease Alcohol and drug abuse BMI>35 Diabetic neuropathy Neurological disorders Coagulation disorders Psychopathy disorders Inappropriate answer to questions
Intervention groups
First group : interscalene nerve block Second group: suprascapular nerve block with axillary nerve block
Main outcome variables
Patient's pain will be evaluated 4, 8, 12 and 24 hours after surgery.

General information

Reason for update
We have reset the recruitment dates.
Acronym
IRCT registration information
IRCT registration number: IRCT20120814010599N23
Registration date: 2018-11-12, 1397/08/21
Registration timing: prospective

Last update: 2020-05-03, 1399/02/14
Update count: 1
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-07, 1397/08/16
Expected recruitment end date
2019-07-05, 1398/04/14
Actual recruitment start date
2018-11-25, 1397/09/04
Actual recruitment end date
2019-08-10, 1398/05/19
Trial completion date
2019-09-10, 1398/06/19
Scientific title
A comparative study of interscalene block and supra scapular block with axillary nerve block, under ultrasound guidance to relieve pain after arthroscopic surgery of shoulder
Public title
Interscalene block and supra scapular block with axillary nerve block, under ultrasound guidance to relieve pain after arthroscopic surgery of shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years old Patients with ASA I,II
Exclusion criteria:
Allergy to local anesthesia Patients with liver disease Alcohol and drug abuse BMI>35 Diabetin Neuropathy Neurological disorders Coagulation disorders Psychological disorders Inappropriate answer to questions
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and person evaluating the outcome will be blinded to the allocated group.
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., next to Milad Tower., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-16, 1396/12/25
Ethics committee reference number
IR.IUMS.FMD.REC1396.9511174016

Health conditions studied

1

Description of health condition studied
Relieve pain after arthroscopic shoulder surgery
ICD-10 code
M 25.5
ICD-10 code description
pain in joint

Primary outcomes

1

Description
Pain after arthroscopic shoulder surgery
Timepoint
4, 8, 12 and 24 hours after surgery
Method of measurement
Using Visual Analogue Scale scale

Secondary outcomes

1

Description
Complications
Timepoint
During 24 hours after surgery
Method of measurement
With physical examination

Intervention groups

1

Description
Intervention group: First group will undergo interscalene nerve block under ultrasound guidance for pain relief after arthroscopic surgery
Category
Treatment - Drugs

2

Description
Intervention group: Second group will undergo suprascapular nerve block with axillary nerve block under ultrasound guidance for pain relief after arthroscopic surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Poupak Rahim Zadeh
Street address
Department of pain، 4th Floor, Hazrat-E-Rasool Hospital, Iran University of Medical Sciences, Niayesh St.,Sattarkahn Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
P-Rahimzadeh@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakuti
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3685
Email
PR@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
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
rahimzadeh.p@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
rahimzadeh.p@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1916737183
Phone
+98 21 8670 2503
Fax
+98 21 6650 9059
Email
rahimzadeh.p@iums.ac.ir

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
Yes - There is 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
Not applicable
Title and more details about the data/document
We have not yet set a conclusion
When the data will become available and for how long
We have not yet set a conclusion
To whom data/document is available
We have not yet set a conclusion
Under which criteria data/document could be used
We have not yet set a conclusion
From where data/document is obtainable
We have not yet set a conclusion
What processes are involved for a request to access data/document
We have not yet set a conclusion
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