Comparison of the anesthesia induced by local injection of lidocaine with and without morphine in digital nerve block in patients with acute hand injury
The aim of this study is comparison of the influence of lidocaine with and without morphine on digital nerve block.
Design
In this open-labeled controlled clinical trial with the parallel group, one hundred twenty-eight (128) patients will be allocated in one of two groups, with the non-randomized method.
Settings and conduct
Patients referring to Department of Emergency Medicine, Imam Khomeini Hospital, Ahvaz with acute injury (less than 6 hours) of fingers requiring digital nerve block will be allocated in one of two groups based on non-randomization method. The intervention group receives the single dose of subcutaneous injection of lidocaine 1% (2.5 ml) plus morphine (2.5 ml) and control group receives the single dose of subcutaneous injection of lidocaine 2% (5 ml). The success of anesthesia, onset of anesthesia, duration of anesthesia will be measured at 0, 5, 15, 30, 60 minutes after drug administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients 15 to 50 years old with acute injury (less than 6 hours) requiring the digital nerve block. Exclusion criteria: arterial bleeding; infected wounds; the presence of the foreign body at the wound site; multiple trauma and mentally retarded patients.
Intervention groups
The intervention group receives the single dose of subcutaneous injection of lidocaine 1% (2.5 ml) plus morphine (2.5 ml) and control group receives the single dose of subcutaneous injection of lidocaine 2% (5 ml).
Main outcome variables
The success of anesthesia; onset of anesthesia; duration of anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032933N2
Registration date:2018-07-10, 1397/04/19
Registration timing:retrospective
Last update:2018-07-10, 1397/04/19
Update count:0
Registration date
2018-07-10, 1397/04/19
Registrant information
Name
Pedram Nazari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 7705
Email address
nazari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2015-07-23, 1394/05/01
Actual recruitment end date
2016-07-22, 1395/05/01
Trial completion date
empty
Scientific title
Comparison of the anesthesia induced by local injection of lidocaine with and without morphine in digital nerve block in patients with acute hand injury
Public title
Effect of lidocaine anesthesia with and without morphine on the digital nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 15 to 50 years old candidate for digital nerve block
Acute injury (less than 6 hours) of fingers
Exclusion criteria:
Arterial bleeding
Infected wounds and foreign body in the wound site
Multiple trauma patients
Mentally retarded patients
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
ajums.REC.1393.306
Health conditions studied
1
Description of health condition studied
Figure injury
ICD-10 code
S64.4
ICD-10 code description
Injury of digital nerve of other finger
Primary outcomes
1
Description
The success of anesthesia
Timepoint
At 0, 5, 15, 30 and 60 minutes after drug administration
Method of measurement
Clinical observations
2
Description
Onset of anesthesia
Timepoint
At 0, 5, 15, 30 and 60 minutes after drug administration
Method of measurement
Clinical observations
3
Description
Duration of anesthesia
Timepoint
At 0, 5, 15, 30 and 60 minutes after drug administration
Method of measurement
Clinical observations
Secondary outcomes
1
Description
Side effects
Timepoint
At 0, 5, 15, 30 and 60 minutes after drug administration
Method of measurement
Clinical observations
Intervention groups
1
Description
Intervention group: Single dose of subcutaneous injection of lidocaine 1% (2.5 ml) plus morphine (2.5 ml)
Category
Treatment - Drugs
2
Description
Control group: Single dose of subcutaneous injection of lidocaine 2% (5 ml)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mofid Hoseinzadeh
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 4355 4063
Email
husseinzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mofid Hoseinzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 1837
Email
husseinzade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mofid Hoseinzadeh
Position
Assistant Professor Of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
husseinzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mofid Hoseinzadeh
Position
Assistant Professor Of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
husseinzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mofid Hoseinzadeh
Position
Assistant Professor Of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
husseinzade@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