Determining the effect of vibration in reducing pain and movement of the patient during spinal anesthesia
Design
Clinical trial with control and intervention group, double-blind, randomized, on 68 patients. Excel software rand function was used for randomization.
Settings and conduct
This study will be performed in Imam Khomeini Hospital. Patients who come to the operating room for abdominal surgery or surgery that can be performed with spinal anesthesia are examined and patients are talked to before the operation and the research process will be explained to patients and patients' informed consent will be obtained and they will enter the study. The group that undergoes spinal anesthesia in the usual way and the other group that undergoes spinal anesthesia by vibrator method
Participants/Inclusion and exclusion criteria
Patients who come to the operating room for abdominal surgery or surgeries with spinal anesthesia will be interviewed before the operation and the research process will be fully explained to the volunteers after filling out the informed consent form. And we include people in the study.
Inclusion criteria for patients:
1. Patients who are candidates for abdominal surgery including hernioraphy, mesh implantation, gastrostomy and jejunostomy
2. Age group 20 to 70 years
3.ASA are also 1-3
Exclusion criteria:
1. Spinal anesthesia should be abolished and we should have to anesthetize the patient with wax for surgery and our anesthesia should not be enough for surgery.
2. The anesthesia is incomplete and we have to use drugs or ketamine to continue the surgery.
Intervention groups
We randomly divide patients into 2 groups:
1. A group for which we perform non-vibratory spinal anesthesia
2. A group where we intervene and place the vibrator in the place where we want to insert the needle
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220107053657N1
Registration date:2022-02-22, 1400/12/03
Registration timing:retrospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Fatemeh Refahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 1226
Email address
shaqayeqrefahi6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-01, 1400/11/12
Expected recruitment end date
2022-02-21, 1400/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vibration in reducing pain and movement of the patient during spinal anesthesia
Public title
Evaluation of vibration in pain in spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for abdominal surgery including herniorrhage, mesh implantation section ,gastrostomy and jejunostomy
Age group 20 to 70 years
They are also ASA 1-3
Exclusion criteria:
Spinal anesthesia should be abolished and we should have to anesthetize the patient with general anesthesia for surgery, and our anesthesia should not be sufficient for surgery.
The anesthesia is incomplete and we have to use drugs or ketamine to continue the surgery.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The list of random allocation of patients will be available only to the epidemiologist of the project. To hide the random allocation process, the corresponding treatment type will be written on 68 cardboard and will be placed in a paper envelope. Only the design methodologist will be aware of the contents of the envelopes. The cards will be arranged in a randomized list inside the box.
Random allocation software is also used for randomization tools. In addition to simple randomization, these random sequence generation software is able to generate random sequences.
When the physician declares a patient eligible, the methodologist will provide the therapist with an envelope design. The person assessing the intended outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. To analyze the data, a statistician who is separate from the study process and is unaware of all the processes performed will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient takes the drug (intervention or comparison group) in sealed envelopes that code
Have been received. Coded by one of the design partners
And the doctor and the evaluator and the patient are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Tehran Province, Tehran, Pour Sina St, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.155
Health conditions studied
1
Description of health condition studied
spinal anesthesia
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anesthesia-induced headache during labor and delivery
2
Description of health condition studied
spinal anesthesia
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
pain
Timepoint
after intervention, one week, one month after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: vibration on location of spinal anesthesia. To perform spinal anesthesia, we sit the patient and in the middle line in the space between the vertebrae L4 and L5, we sterilize the area where the needle enters and we put the vibrator device in the sterile cover and we put it for 30 seconds to 1 minute and then a little We move and finally continue the vibration at the entrance of the needle and under the supervision of a doctor under constant anesthesia, insert the needle during the study process and then remove the mandrel and after removing the CSF fluid (cerebrospinal fluid) local anesthetic We prescribe 0.5% bupivacaine depending on the surgical site between 10-15 mg and then remove the needle and bandage the site and put the patient to sleep in supine position.
Category
Treatment - Devices
2
Description
Control group: Spinal anesthesia was performed without vibrator. To perform spinal anesthesia, we sit the patient and sterilize the area where the needle is inserted in the middle line in the space between L4 and L5 vertebrae. When CSF (cerebrospinal fluid) is removed, we prescribe a local anesthetic, bupivacaine 0.5%, depending on the surgical site, between 15 and 15 mg, and then remove the needle, bandage the area, and put the patient to sleep in a supine position.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Nader Ali Nazemian Yazdi
Street address
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
hamiralam@sina.tums.ac.ir
Grant name
Vice Chancellor for Research, Tehran University of Medical Sciences
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
Nader Ali Nazemian Yazdi
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
shaqayeqrefahi6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
shaqayeqrefahi6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran, Enghelab St. (Darvazeh Dolat), the beginning of Saadi St.
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6634 3352
Email
shaqayeqrefahi6@gmail.com
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