Comparison of intercostobrachial nerve block with axillary nerve block effects on tourniquet pain in patients undergoing upper limb surgeries who got infra clavicular block under sonographic guide
Tourniquet pain severity in patients group under intercostobrachial nerve block based on Numeric Rating Scale every 30 minutes during surgery
Tourniquet pain severity in patients group under axillary nerve block based on Numeric Rating Scale every 30 minutes during surgery
Comparison of tourniquet pain severity in patients group under intercostobrachial nerve block and axillary nerve block
Comparison of the pethidine dosage use for pain relief between two groups
Design
Randomized single-blinded with parallel groups clinical trial on 30 patients
Settings and conduct
In this study 30 cases chosen randomly in two groups. All the cases will get infraclavicular block. To reduce tourniquet pain during surgery one group will get axillary nerve block and the other group will get intercostobrachial nerve block. During the surgery we will ask the cases about their pain according to NRS score every 30 minutes. After surgery the limb will be assessed according to the block. Finally the patients' satisfaction will be measured by questionnaire.
Participants/Inclusion and exclusion criteria
Patients satisfaction verbal and written to join the study
Patient age range between 12 to 70 years old
Patients with American Society of Anaesthesiologists score 1 or 2
Patients candidate for upper limb surgeries from elbow to distal parts of limb
Weight more than 50 kilograms
Intervention groups
Patients undergoing upper limb surgeries
Main outcome variables
Pain reduction in parts of the limbs under tourniquet, during and after srgery
Reduction in opioid use for analgesia
Reduction of becoming a surgery with local anesthesia to a surgery with general anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220814055683N1
Registration date:2023-01-19, 1401/10/29
Registration timing:registered_while_recruiting
Last update:2023-01-19, 1401/10/29
Update count:0
Registration date
2023-01-19, 1401/10/29
Registrant information
Name
Hamidreza Khabaz nayab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 4926
Email address
hamidreza.khabaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intercostobrachial nerve block with axillary nerve block effects on tourniquet pain in patients undergoing upper limb surgeries who got infra clavicular block under sonographic guide
Public title
Comparison of two types of local anesthesia on tourniquet pain in upper limbs surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction written and verbal
Patient age range between 12 and 70 years old
ASA score 1 or 2
Patients candidate for upper limb surgeries from elbow to distal parts of the limb
Weight more than 50kg
Exclusion criteria:
Patient satisfaction oral and written
Age range between 12 to 70 years old
A.S.A grade 1 or 2
patients candidate for upper limbs surgery from elbow to distal regions of the limbs
Patients weight more than 50 kg
Age
From 12 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization to two groups based on randomized blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not aware of the intervention type, it is a single blind study
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 science,East Hemmat
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-06-07, 1401/03/17
Ethics committee reference number
IR.IUMS.FMD.REC.1401.115
Health conditions studied
1
Description of health condition studied
Upper limb surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient pain score
Timepoint
during surgery and recovery
Method of measurement
NRS questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intercostobrachial block on patients candidate for upper limb surgeries from elbow to distal, who have taken infra-clavicular block as the main block
Category
Prevention
2
Description
Axillary nerve block on patients candidate for upper limb surgeries from elbow to distal, who have taken infra-clavicular block as the main block
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram_firoozgar hospital
Full name of responsible person
Hamidreza Khabaz Nayab
Street address
Rasool akram hospital, Mansoori st, Sattarkhan st
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1111
Email
Rasoolhospital@iums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Hemmat expressway, Iran university of science
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
keyvani.h@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
Hamidreza Khabaz nayab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahre ziba, moradi ave
City
Tehran
Province
Tehran
Postal code
1486893958
Phone
+98 21 4435 4926
Fax
Email
Hamidreza.khabaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamidreza Khabaz nayab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahre ziba, moradi ave
City
Tehran
Province
Tehran
Postal code
1486893958
Phone
+98 21 4435 4926
Fax
Email
Hamidreza.khabaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamidreza Khabaz nayab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahre ziba, moradi ave
City
Tehran
Province
Tehran
Postal code
1486893958
Phone
+98 21 4435 4926
Fax
Email
Hamidreza.khabaz@gmail.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