Determining the outcome and complications of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis
Design
60 patients will be randomly assigned to groups with and without intrathecal morphine injection using computer numbers generated by Random Allocation software (30 patients in each group). For patients in the intervention group, 3 micrograms of morphine per kilogram of body weight will be injected intratracheally before anesthesia. Routine treatment will be performed in the control group.
Settings and conduct
In this single-blind clinical trial, candidates for posterior fusion surgery of patients with idiopathic scoliosis referred to Imam Khomeini Hospital will be included in the study after obtaining informed consent. The participant will be unaware of being placed in the group with and without intrathecal morphine injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients needing posterior fusion surgery, patients with idiopathic scoliosis referred to Imam Khomeini Hospital , aged 10 to 20 years, with physical status I, II of the American Society of Anesthesiologists (ASA).
Exclusion criteria: symptoms of L2-3 intervertebral nerve injury
Known allergy to one or more drugs used in the study protocol
History of corticosteroid use
Opium and NSAIDs in at least one week
Coagulation dysfunction, infection at the puncture site
Cognitive impairment (inability to understand VAS)
Body mass index (BMI) greater than 35 kg/m2
.
Intervention groups
60 patients will be randomly assigned to the group with and without intrathecal morphine injection (30 patients in each group).
Main outcome variables
Nausea, vomiting, pain in recovery, need for narcotic drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240217061034N1
Registration date:2024-04-12, 1403/01/24
Registration timing:prospective
Last update:2024-04-12, 1403/01/24
Update count:0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
Mirbahram Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
safari.mb@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-19, 1403/01/31
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the outcome and side effects of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis
Public title
Investigating the outcome and side effects of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need of posterior fusion surgery, patients with idiopathic scoliosis referred to Imam Khomeini Hospital , 10 to 20 years old
with physical status I, II, American Society of Anesthesiologists (ASA)
Children with idiopathic scoliosis in the range of 10 to 20 years
Exclusion criteria:
Symptoms of L2-3
intervertebral nerve injury Known allergy to one or more drugs used in the study
protocol History of corticosteroid use Opium and NSAIDs
in at least one week Coagulation dysfunction,
infection at the puncture site Cognitive impairment (inability to understand VAS)
Body mass index (BMI) greater than 35 kg/m2
Age
From 10 years old to 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding will be like this, the participant will be unaware of being in the group with and without intrathecal morphine injection. Thus, for patients in the intervention group, morphine will be injected intrathecally before anesthesia, and no explanation will be given to the patient about the injected substances or its consequences. For patients in the control group, routine treatment will be performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini Medical Education Center - Urmia University of Medical Sciences
Street address
Emam khomini university hospital-Eershad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2023-10-24, 1402/08/02
Ethics committee reference number
IR.UMSU.HIMAM.REC.1402.096
Health conditions studied
1
Description of health condition studied
Outcome and complications of intrathecal morphine injection in posterior fusion surgery of patients with idiopathic scoliosis
ICD-10 code
M41.0
ICD-10 code description
Infantile idiopathic scoliosis
Primary outcomes
1
Description
Pain intensity based on the pain felt by the patient
Timepoint
In recovery, it will be evaluated 0 to 2, 2 to 6, 6 to 12, and 12 to 24 hours after the operation.
Method of measurement
pain scale (VAS)
2
Description
Nausea/vomiting/itching
Timepoint
In recovery, it will be evaluated 0 to 2, 2 to 6, 6 to 12, and 12 to 24 hours after the operation.
Method of measurement
Physical examination
3
Description
The first time to ask for painkillers
Timepoint
24 hours after the operation
Method of measurement
Painkiller request by the patient
Secondary outcomes
empty
Intervention groups
1
Description
3 micrograms per kilogram of body weight, morphine of Daro Parseh Tehran Company will be injected intratracheally before anesthesia; Intrathecal injection of morphine is a less complicated process; In case of blood pressure drop, serum will be injected and naloxone will be injected in case of itching.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment will be done
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences, Imam Khomeini Hospital
Full name of responsible person
Mir Bahram Safari
Street address
Emam khomini university hospital-Eershad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 914 340 7811
Email
safari.mb@umsu.ac.ir
Web page address
https://umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia, Resalat Koi Emergency Blvd Central headquarters of Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3223 5070
Email
saber@umsu.ac.ir
Web page address
https://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Mir Bahram Safari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Emam khomini university hospital-Eershad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
0098443469931
Email
safari.mb@umsu.ac.ir
Web page address
https://umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Mir Bahram Safari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Emam khomini university hospital-Eershad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
کدپستی5715781351
Phone
0098443469931
Email
safari.mb@umsu.ac.ir
Web page address
https://umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Mir Bahram Safari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Emam khomini university hospital-Eershad AVE-Modarres Blvd-urmia-iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
0098443469931
Email
safari.mb@umsu.ac.ir
Web page address
https://umsu.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