Protocol summary

Study aim
The aim of this study is to evaluate the analgesic effect of lidocaine, pethidine and the combined of both in the Beirblock method in patients with distal radius fractures referred to the orthopedic operating room of Shahid Bahonar Hospital in Kerman in 2022.
Design
Clinical trial has 3 groups, with factorial groups (Control group: lidocaine (3mg/kg) Intervention group1: pethidine (0/6mg/kg) Intervention group2: both lidocaine (3mg/kg) and pethidine (0/6mg/kg) ) ,double-blind, randomized, phase 2 on 90 patients. Using random numbers a third party will assign them to three groups.
Settings and conduct
Location: Operating room of Bahonar Hospital in Kerman Double-blind. Before starting the patient's VAS will be measured.Drugs will be injected intravenously then a tourniquet will be placed on the arm of the operated hand. Cuff pressure will 150 mm Hg above systolic pressure, A minimum of 250 mm Hg will be adjusted. The disappearing of the radial pulse will confirm sufficient tourniquet pressure. Then the complications of CNS and heart and the amount of sensory and motor block will be evaluated.Due to the colorlessness of the drugs, the patient will be blind. Only the anesthesiologist will be aware of the type of medication, and therefore the assessing physician will be unaware of the analgesic treatment protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: distal radius fracture and age between 18 to 65 years Exclusion criteria: Allergy to local anesthetics, heart, Kidney ,Lung ,Brain disease Diabetes, Allergy to pethidine and other drugs and Drug users
Intervention groups
Control group: lidocaine (3mg/kg) group1: pethidine (0/6mg/kg) group2: both lidocaine (3mg/kg) and pethidine (0/6mg/kg)
Main outcome variables
Pain sensation is assessed based on VAS. The degree of sensation of touch will be scored from zero to two (no sense: zero, vague sense: 1 and full sense: 2)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211224053507N1
Registration date: 2022-01-28, 1400/11/08
Registration timing: prospective

Last update: 2022-01-28, 1400/11/08
Update count: 0
Registration date
2022-01-28, 1400/11/08
Registrant information
Name
Mansour Mortezazadeh Meimand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 9181
Email address
drm7039970399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of lidocaine, pethidine and their composition in Bier Block anesthesia in patients with distal radius fracture
Public title
Comparison of the effect of pethidine, lidocaine the combined of both on pain management in local anesthesia in wrist fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Distal radius fracture Age between 18 and 65 years
Exclusion criteria:
Allergy to local anesthetics Uncontrolled heart disease Kidney diseases Lung diseases Brain diseases Diabetes Allergy to pethidine and other drugs Drug users Dissatisfaction with participation in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were randomly divided into 3 groups of 30 using a sequence of random numbers made by SAS statistical software. Based on this method, a random list of numbers is made and the assignment of patients to groups is determined based on the order of their entry. Sealed, opaque numbered envelopes were used to hide randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed in a double-blind manner. The drugs will be injected intravenously. Due to the colorlessness of the drugs, the patient will be blind. Only the anesthesiologist will be aware of the type of medication, and therefore the researcher and the assessing physician will be unaware of the analgesic treatment protocol.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman university of medical science
Street address
Shahid Bahonar Hospital., Sepah St., Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2021-11-24, 1400/09/03
Ethics committee reference number
IR.KMU.AH.REC.1400.203

Health conditions studied

1

Description of health condition studied
Fracture of lower end of radius
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
The pain score in each group
Timepoint
Ten minute intervals until the end of the operation
Method of measurement
Numeric pain intensity scale (VAS Scoring system)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: receive lidocaine (3mg/kg)
Category
Treatment - Drugs

2

Description
Intervention group: receive pethidine (0/6mg/kg)
Category
Treatment - Drugs

3

Description
Intervention group: receive both lidocaine (3mg/kg) and pethidine (0/6mg/kg)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital of Kerman
Full name of responsible person
Jafar Salehi
Street address
Shahid Bahonar Hospital., Sepah St., Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
DR.Jsalehi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Somayeh crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mansour Mortezazadeh Meimand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
DRM7039970399@GMAil.Com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Jafar salehi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
DR.Jsalehi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansour Mortezazadeh Meimand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Gharani
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
DRM7039970399@GMAil.Com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, some of the information, including the effect of prescribing her, pethidine , lidocaine and the combination of both on the bier block anesthesia on distal radius fractures surgery, it will share with health workers.
When the data will become available and for how long
2 months after data analysis
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Mansour Mortezazadeh Meimand-Email
What processes are involved for a request to access data/document
The purpose of accessing data - requesting e-mail-After a week
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