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Comparative Evaluation of Paramedian Approach versus Modified Paramedian Approach in Spinal Anesthesia Administration: A Study on Procedural Ease and Patient Satisfaction in Surgical Procedures

Protocol summary

Study aim
Determining the comparison of the lateral approach (paramedin) versus the modified lateral approach (modified paramedin) in spinal anesthesia in terms of the ease of the procedure and patient satisfaction after surgery
Design
: Clinical trial with a control group, with parallel groups, two blinded, randomized, phase 3 on 112 patients.
Settings and conduct
This study, a clinical trial with control group, with parallel groups, double-blind, randomized, will be conducted on 112 patients candidates for lower surgery in hospitals affiliated to Iran University of Medical Sciences. Patients will be divided into two groups of 56 people. Patients will be randomly assigned to two groups, without being aware of the type of spinal anesthesia (paramedin or modified paramedin) that will be performed on them. Also, the researcher who collects the information is also unaware of the type of intervention of the patients. In addition, the statistician will not be aware of the type of interventions for data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who need spinal anesthesia and are in the age group of 18-70 years and classified (ASA) in class one. Exclusion criteria: Patients with the prohibition of using spinal anesthesia and the presence of infection at the injection site of spinal anesthesia, A history of taking anticoagulants in the last 3 months. personal dissatisfaction,
Intervention groups
The patients who are going to undergo spinal anesthesia by paramedian method will be called P group and the patients who are going to undergo spinal anesthesia by modified paramedian method will be called MP group.
Main outcome variables
Satisfaction of post-spinal patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161220031487N10
Registration date: 2024-09-06, 1403/06/16
Registration timing: registered_while_recruiting

Last update: 2024-09-06, 1403/06/16
Update count: 0
Registration date
2024-09-06, 1403/06/16
Registrant information
Name
مهرداد Mesbah kiaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 346 5866
Email address
dr.mmesbah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-09, 1403/04/19
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Paramedian Approach versus Modified Paramedian Approach in Spinal Anesthesia Administration: A Study on Procedural Ease and Patient Satisfaction in Surgical Procedures
Public title
Comparing the paramedian approach versus the modified paramedian approach in performing spinal anesthesia in terms of ease of performing the procedure and patient satisfaction after surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need spinal anesthesia Age group: 18 to 70 years old Physical status according to ASA classification classes I, II, and III
Exclusion criteria:
Patients with contraindications to spinal anesthesia presence of infection at the site of spinal anesthesia injection, Lack of personal consent, Obesity with BMI > 38 kg/m2, Uncontrolled type 1 and 2 diabetes mellitus, Uncontrolled hypertension history, Moderate to severe valvular heart diseases, Neurological and psychiatric disorders such as stroke, history of brain lesions, obsessive-compulsive disorder, and schizophrenia, Fever exceeding 37.5 degrees Celsius at the beginning of the surgery, History of alcohol consumption, drug abuse, or misuse of sedatives-hypnotics and glucocorticosteroids,
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block randomization method will be employed using randomly arranged blocks of four. To generate the block randomization, Excel software and the RAND function were utilized. Initially, all possible combinations of the two treatment groups were entered into a column of an Excel worksheet. Subsequently, for each of these combinations, a random number was generated in the adjacent column using the RAND function, which produces a random number between 0 and 1, assigned to each block. When it is stated that "blocks will be randomly selected using Excel," it means that after generating random numbers for each block using the RAND function, the blocks are sorted based on these numbers. This random arrangement of blocks is then applied in the study to randomly assign patients to treatment groups. A numerical code is assigned to each block, and these codes, along with the assigned treatment regimen, are recorded and maintained by the epidemiologist responsible for the randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients were randomly assigned to two groups, without knowing the type of spinal anesthesia (paramedian or modified paramedian) they were given. Also, the researcher who collects the information is also unaware of the type of intervention of the patients. In addition, the statistician will not be aware of the type of interventions for data analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Medicine - Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-07-09, 1403/04/19
Ethics committee reference number
IR.IUMS.FMD.REC.1403.194

Health conditions studied

1

Description of health condition studied
Spinal anesthesia technique
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Ease of performing the spinal anesthesia procedure
Timepoint
After performing the technique, by a person who is unaware of the study process; The relevant expert will be asked about the degree of difficulty of the process.
Method of measurement
questionnaire

2

Description
Patient satisfaction after surgery
Timepoint
After performing the technique, at the beginning of the surgery, at the end of the surgery, at the beginning of the patient's entry into recovery and at the time of the patient's discharge from the recovery department, the patient will be asked about the patient's satisfaction with the anesthesia process by a person who is unaware of the study process.
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients who are going to undergo spinal anesthesia using the modified paramedian method will be called the MP group. In this group, the patients will be placed in a sitting position and the needle will be guided 2-3 cm outside and 2-3 cm below the spinous appendage of the desired space with an angle of 30-45 degrees up and inside. And in both groups, 2 to 3 ml of 0.5% bupivacaine was prescribed in the subarachnoid space.
Category
Treatment - Surgery

2

Description
Control group: The patients who are going to undergo spinal anesthesia by paramedian method will be called P group. . Spinal anesthesia with the standard paramedian method in group P in the L3-L4 or L4-L5 intervertebral space with a 27 Quincke type needle while the patient is sitting; The needle will be guided 1 cm outside and 1 cm below the spinous appendage of the desired space with an angle of 10 to 15 degrees upwards and inside.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Hashminejad Hospital
Full name of responsible person
Mehrdad Mesbah Kiaee
Street address
Shahid Hashemi Nejad Hospital, Shahid Vali Nejad Alley, Above Vanak Square, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
hkc.iran2023@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Mesbah Kiaee
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Mesbah Kiaee
Position
Cardiac anesthesia fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Hashemi Nejad Hospital, Shahid Vali Nejad Alley, Above Vanak Square, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
dr.mmesbah@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Mesbah Kiaee
Position
Cardiac anesthesia fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Hashemi Nejad Hospital, Shahid Vali Nejad Alley, Above Vanak Square, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
dr.mmesbah@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Mesbah Kiaee
Position
Cardiac anesthesia fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Hashemi Nejad Hospital, Shahid Vali Nejad Alley, Above Vanak Square, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
dr.mmesbah@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information related to the original message or similar It is possible to share.
When the data will become available and for how long
Access period 6 months after publication of results
To whom data/document is available
Available only to researchers working in academic and scientific institutions will be.
Under which criteria data/document could be used
No special conditions are considered.
From where data/document is obtainable
Mehrdad Mesbah Kiaee- dr.mmesbah@gmail.com
What processes are involved for a request to access data/document
After receiving the applicant's email, send the documents in a short period.
Comments
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