Protocol summary

Study aim
By determining and comparing the combined interscalene and supraclavicular block of the brachial plexus with the interscalene and supraclavicular method alone in arm surgeries, positive steps can be taken in this regard.
Design
Clinical trial with one intervention group and two control groups, double-blind, randomized, phase 3 on 150 patients. Random block allocation with 4 blocks is used for randomization.
Settings and conduct
The study site at Shahid Beheshti Hospital in Ghoum will be a random selection between patients in need of arm surgery, to be placed in the intervention group (the group to which both nerve blocks are applied) or the control group (which is only one of the Two types of neural blocks are applied to them (random block method of 4 blocks will be used, double-blindness will include the patient himself, the data recorder and the data analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient is over 18 years old, has a broken arm and needs surgery, and has American Stroke Association (ASA) 1, 2; Exclusion criteria: The patient is addicted to drugs, is pregnant, has a history of allergy to local anesthetics, and is not satisfied with the inclusion in this study.
Intervention groups
Intervention group 1: For these patients, both interscalene and supraclavicular block methods are used. Intervention group 2: For these patients, only interscalene method is used for arm reticular block. Intervention group 3: For these patients, only the supraclavicular method is used for blocking the neural network.
Main outcome variables
Reducing the need for painkillers to control postoperative pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211017052786N3
Registration date: 2022-07-06, 1401/04/15
Registration timing: registered_while_recruiting

Last update: 2022-07-06, 1401/04/15
Update count: 0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Amir Hossein Moradi Rafigh
Name of organization / entity
Qom university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3885 6440
Email address
amirmmr287@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of intracranial and supraclavicular combined block of the brachial plexus under ultrasound guide compared to single intracclanic and supraclavicular block in arm surgeries
Public title
Comparison of the success rate of combined block in arm surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with American Stroke Association (ASA) 1, 2 Patients with arm fractures require surgery Patients over 18 years of age
Exclusion criteria:
Drug addiction Patient dissatisfaction Being pregnant has a history of allergy to local anesthetics
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using 4 blocks, randomization criterion is done using random block allocation with 4 blocks, which have all four modes (a a b b), (a b a b), (b b a a) and (b a b a) are written on four cards and the four patients are randomly grouped, respectively. The head of the ward takes the patient card out of the bag and the patients are divided into groups by lot. For example, if the lottery is (a a b b), the first and second patients are in the first group, and the third and fourth patients are in the second group, and also for the next four patients, a card is issued again.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person filling out the questionnaire and the patient will not know the type and method of local anesthetic of the patient. The anesthesiologist will not interfere in the data recording or analysis process.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ghoum University of Medical Sciences
Street address
No.10, 13th Ave., Emam Street.
City
Ghoum
Province
Ghoum
Postal code
3718913997
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.MUQ.REC.1401.059

Health conditions studied

1

Description of health condition studied
Local anesthesia to the arm, forearm and hand
ICD-10 code
T81.8
ICD-10 code description
Other complications of procedures, not elsewhere classified

Primary outcomes

1

Description
Pain medication required
Timepoint
6 and 12 hours after surgery
Method of measurement
Visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Interscalene block combined with superclavicular block; 100 mg of lidocaine 1% with 40 mg of marcaine 025. Epinephrine will be injected in half volume in the SUPRACLAVICULAR section and the other half in the INTERSCALANE section.
Category
Treatment - Other

2

Description
Control group 1: Only the superclavicular block; 100 mg of lidocaine 1% with 40 mg of marcaine 0.25% Epinephrine.
Category
Treatment - Other

3

Description
Control group 2: Interscalene block only; 100 mg of lidocaine 1% with 40 mg of marcaine 0.25 % Epinephrine.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Abbas Ahmadi
Street address
Shahid Beheshti Blvd
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
Bmc@muq.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mostafa vahedian
Street address
No. 83, Forth Ave., Safa Shahr Street
City
Ghoum
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
vahedian58@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Amir Hossein Moradi Rafigh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Ghoum
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gamil.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Amir Hossein Moradi Rafigh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Ghoum
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Hossein Moradi Rafigh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No. 46, 32th Ave., Keshavarz Shomali Blvd.
City
Ghoum
Province
Ghoum
Postal code
3715178817
Phone
+98 25 3885 6440
Email
Amirmmr287@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data are specific to the present study. There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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