Comparison of the effect of morphine by intranasal and intravenous methods in orthopedic surgeries in the upper limb in patients referred to 17 Shahrivar Amol Hospital in 1400
Design
Clinical trial with two intervention groups, one-way blind, randomized with permutation block randomization on 78 patients
Settings and conduct
The study site of the operating room of 17 Shahrivar Amol Hospital is on patients who are candidates for surgery on the upper limb, who will receive morphine for intravenous and intranasal methods to relieve pain. Blinding is done only by the analyzer.
Participants/Inclusion and exclusion criteria
Age 18- 65 years
Upper limb fractures under general anesthesia
Willingness to participate in the study
Natural GCS
Weight 60-100 kg
Operating time up to 3 hours
No underlying diseases
No head injuries
More than 12 breaths per minute
Systolic blood pressure greater than 110 mm Hg
SPO2 greater than 95% in room air
Intervention groups
In group A, people will receive 2 cc of intravenous morphine after surgery to relieve pain. In group B, people receive 2 cc of morphine intranasally using a dropper in each nostril 24 drops (48 drops in total).
Main outcome variables
Pain relief in the intranasal morphine group will be faster than intravenous and the side effects of the drug will be less.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210328050784N1
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Nasrin Gaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4000
Email address
nasringhaffari.amo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of morphine effect by intranasal and intravenous methods in orthopedic surgeries in the upper limb
Public title
Comparative study of morphine effect by intranasal and intravenous methods in orthopedic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for orthopedic surgery for upper limb fractures under general anesthesia
Agree to participate in the study
Natural GCS (score 15) based on the Glasgow scale
Weight between 60 to 100 kg
Duration of operation up to 3 hours
No underlying diseases including diabetes, liver and kidney disease, COPD and coagulation disorders
Lack of sensitivity to drugs
No addiction
No head injuries during the accident
More than 12 breaths per minute
Systolic blood pressure greater than 110 mm Hg
SPO2 More than 95% in room air
Exclusion criteria:
Dissatisfaction with continuing to participate in the project
Prolongation of surgery time more than 3 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random sampling method will be used.
Randomization block permutation was used to assign groups.
Patients participating in the study will be divided into two groups of 39 using 4 blocks and letters A and B (for group equality).
For block permutation randomization, the sealed envelope method with random sequence will be used. A sealed envelope containing the two letters A and B is inserted into the patient file, which is opened before the operation. People in group A will receive morphine intravenously and people in group B will receive intranasal morphine.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method will be one-way blind and only by the analyzer. Due to the knowledge of the facilitator and the researcher, as well as the patient about the method of using the drug, they will not be able to blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Headquarters of Mazandaran University of Medical Sciences, The beginning of Valiasr Highway,Three ways Jouybar, Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.MAZUMS.REC.1399.911
Health conditions studied
1
Description of health condition studied
Orthopedic surgeries on the upper limbs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
10, 30, 60 minutes and 2 and 4 hours after drug administration
Method of measurement
VAS scale
2
Description
Nausea
Timepoint
10, 30, 60 minutes and 2 and 4 hours after drug administration
Method of measurement
VAS Nausea Scale
3
Description
Vomiting
Timepoint
10, 30, 60 minutes and 2 and 4 hours after drug administration
Method of measurement
Frequent vomiting: Less than once: Mild,Between 1-3 times: Medium,More than 3 times or howling: severe
4
Description
Itching
Timepoint
10, 30, 60 minutes and 2 and 4 hours after drug administration
Method of measurement
Asking: yes / no
5
Description
Vertigo
Timepoint
10, 30, 60 minutes and 2 and 4 hours after drug administration
Method of measurement
Asking: yes / no
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First: Use of 2 cc morphine by intravenous injection in recovery to relieve patient pain
Category
Treatment - Drugs
2
Description
Intervention group: Second: using 2 cc of morphine by intranasal method, which is poured into each nostril using 24 drops.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Amol Hospital
Full name of responsible person
Nasrin Ghaffari vasati
Street address
next to the Red Crescent, Red Crescent Street ,Amol,Mazandaran
City
Amol
Province
Mazandaran
Postal code
۴۲۲۴۰۰۱۰۱۱
Phone
+98 11 4422 4001
Email
tajnoor2010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Headquarters of Mazandaran University of Medical Sciences, The beginning of Valiasr Highway,Three ways Jouybar, Imam Square, Sari
City
Amol
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Nasrin Ghaffari vasati
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
17 Shahrivar Amol Hospital, Mazandaran
City
Amol
Province
Mazandaran
Postal code
9691738135
Phone
+98 11 4422 4002
Email
nasringhaffari.amo@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Bouali Hospital, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
96917383135
Phone
+98 11 3334 4507
Email
Hooshangakbari48@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nasrin Ghaffari Vasati
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
end of the sea 1/22, Adl building, second floor, unit 4, Amol, Mazandaran
City
Amol
Province
Mazandaran
Postal code
9691738135
Phone
+98 11 4308 6154
Email
nasringhaffari.amo@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
It will not be published due to the dissatisfaction of the participants in publishing the information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information and results obtained from the study will be published in the form of an article.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
If the data is not misused, they will be usable.
From where data/document is obtainable
Nasringhaffari.amo@gmail.com
What processes are involved for a request to access data/document
After the request, the results will be available to the applicant by email.