Comparing the anesthetic effect of topical amitriptyline jell 2% versus topical lidocaine jell 2% in patients with isolated limb wounds needing primary repair with suture: a randomized clinical trial
To compare the anesthetic effect of topical amitriptyline jell 2% versus topical lidocaine jell 2% in patients with isolated limb wounds needing primary repair with suture
Design
This a randomized clinical trial, phase II, in which 90 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with isolated limb wounds needing primary repair with suture who will refer to Besat Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 60 years
Having isolated limb wounds needing primary repair with suture
Exclusion criteria:
Using monoamine oxidase inhibitors
Cardiovascular diseases
Arterial active bleeding
Unstable vital signs
Intervention groups
Intervention group: Topical amitriptyline 2% with the amount of 2 mg/kg single dose
Control group: Topical lidocaine 2% with the amount of 2 mg/kg single dose
Main outcome variables
Primary outcome: Assessing the pain before suture and at 1, 3, 5, 7, and 9 minutes after suture using VAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N216
Registration date:2018-03-20, 1396/12/29
Registration timing:registered_while_recruiting
Last update:2018-03-20, 1396/12/29
Update count:0
Registration date
2018-03-20, 1396/12/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the anesthetic effect of topical amitriptyline jell 2% versus topical lidocaine jell 2% in patients with isolated limb wounds needing primary repair with suture: a randomized clinical trial
Public title
Comparing the anesthetic effect of topical amitriptyline jell 2% versus topical lidocaine jell 2% in patients with isolated limb wounds needing primary repair with suture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 60 years
Having isolated limb wounds needing primary repair with suture
Exclusion criteria:
Using monoamine oxidase inhibitors
Cardiovascular diseases
Arterial active bleeding
Unstable vital signs
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.811
Health conditions studied
1
Description of health condition studied
Isolated limb wounds
ICD-10 code
S81
ICD-10 code description
Open wound of knee and lower leg
Primary outcomes
1
Description
Assessing the pain
Timepoint
Before suture and at 1, 3, 5, 7, and 9 minutes after suture
Method of measurement
Using VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical amitriptyline 2% with amount of 2 mg/kg single dose
Category
Treatment - Drugs
2
Description
Control group: Topical lidocaine 2% with amount of 2 mg/kg single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Farnoosh Jalilvand
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
hila_kool@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Farnoosh Jalilvand
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
hila_kool@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rasool Salimi
Position
Emergency Medicine Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
rasoulsl@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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