Pain control in patients with closed distal forearm fractures
Design
Two arm parallel group randomized trial with blinded intervention and outcome assessment
Settings and conduct
This study will be carried out at the emergency department of Sina Hospital, Tehran, Iran.
The study is double blind. Patients, the person who will perform the procedure, as well as the person who measures the severity of pain, will be unaware of the groups.
Participants/Inclusion and exclusion criteria
Patients over the age of 18-year-old suffer from closed distal forearm fracture and class 1 or 2 according to the classification of American Society of Anesthesiologists are included.
If there is any evidence of concurrent head trauma, multiple trauma, open fracture, compartment syndrome, or any contraindication or drug allergy to morphine or lidocaine are excluded.
Intervention groups
Intervention group: Priosteal block with lidocaine + intravenous placebo
Control group: Local injection of placebo + intravenous morphine
Main outcome variables
In this study, visual analog scale will be used to measure pain intensity. In this way, this criterion will be recorded in both groups before injection and at 0, 15, 30, 45, and 60 minutes, and 75.90 after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131203015640N6
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Alireza Baratloo
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0432
Email address
alirezabaratloo@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-15, 1396/11/26
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of periosteal block vs. intravenous morphine on reducing the pain of patients with distal radius and ulnar fracture
Public title
Periosteal block vs. intravenous morphine on reducing the pain of patients with distal forearm fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Closed distal radius and/or ulnar fracture
American Society of Anesthesiologists (ASA) class 1, 2
Exclusion criteria:
Open fractures
Neurovascular compromise
Multiple trauma
Head Trauma
Suspicion for compartment syndrome
Allergy or contraindication for lidocaine or morphine administration
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
After entering the study, the patients are randomly divided into two groups and one group received intravenous morphine and local injection of placebo and the other group intravenous placebo and periosteal block. The procedure is carried out by a person who is unaware of the type of drugs and the assessment of pain is done by another person, who is also unaware of the groups.
Placebo
Used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Building no 1, School of medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2838
Health conditions studied
1
Description of health condition studied
Patients with closed distal forearm fracture
ICD-10 code
S52.6
ICD-10 code description
Fracture of lower end of both ulna and radius
Primary outcomes
1
Description
Pain score
Timepoint
Minutes 0, 15, 30, 45, 60, 75 and 90 after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To perform the periosteal block, using a 10cc syringe containing lidocaine 1% at a distance of 6-8 cm proximal to the wrist of the lateral of the radius bone and medial of the ulnar bone are injected. In this group, distilled water will be injected intravenously as placebo.
Category
Treatment - Drugs
2
Description
Control group: Morphine sulfate with a dose of 0.1 mg/kg body weight and diluted in pre-prepared syringes with distilled water, so that each cc contains 1 mg of morphine. This amount will be infused slowly through the peripheral vein within 5 minutes. Block operations will also be performed using distilled water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Ali Abdolrazaghnejad
Street address
Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 8432
Email
ali.abdorazzagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Deputy of research and technology, Tehran University of Medical Sciences, Keshavarz Bulvard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
tums_res@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 8432
Email
ali.abdorazzagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 8432
Email
ali.abdorrazagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Baratloo
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 8432
Email
alirezabaratloo@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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Base information of the participants in the study, information on the main outcome and possible side effects
When the data will become available and for how long
starting Instantly after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Any analysis is allowed
From where data/document is obtainable
Contact with ali.abdorazzagh@gmail.com
What processes are involved for a request to access data/document